Pages

Saturday, May 31, 2014

FDA warns against recalled anti-depression drugs

May 27, 2014 8:06pm
 
Philippine health authorities on Tuesday advised the public against buying three batches of anti-depression drugs that had been recalled by their manufacturer.
 
The Food and Drug Administration said GlaxoSmithKline USA recalled batches of its Paroxetine 20mg tablet (Seroxat) that were made in Romania.
 
"A Warning Letter was issued by the US FDA to GlaxoSmithKline (GSK), USA because the active Pharmaceutical Ingredients (API) manufacturer, SmithKline Beecham (Cork) Ltd. at Currabinny Carriagaline Cork, Ireland had critical deviations which caused the Paroxetine API to be adulterated," FDA head Kenneth Hartigan-Go said in FDA Advisory 2014-038.
 

While the advisory was dated May 12, it was posted on the FDA website only on Tuesday.
 
Covered by the voluntary recall are batches 601, 602M, and 603.
 
Hartigan-Go said proxetine is used for treatment of depression, obsessive-compulsive disorder and panic disorder with or without agoraphobia or the fear of public places.
 
The FDA advised consumers to buy their medicines from legitimate pharmacies and drug outlets and ask for official receipts.
 
"If you happen to buy batches of Seroxat that are subject of product recall, the consumer may report to FDA via report@fda.gov.ph or to GalxoSmithKline Philippines Inc at tel. nos.: +6328648516 and +6328920762 ext. 8643 or mobile nos.: +639178882315 and+639178594598," it said.
 
Suspected adverse reactions should be reported immediately to FDA by visiting www.fda.gov.ph. Joel Locsin/NB, GMA News

FDA: Not all Eli Lilly products covered by recall order

May 30, 2014 5:29pm
The Food and Drug Administration on Friday said certain products from pharmaceutical firm Eli Lilly may still be sold, citing a stay order from the office of Health Secretary Enrique Ona.

In Advisory 2014-043 dated May 30, the FDA said the following products, which have valid product registration, are allowed in the Philippine market:
  • Gemzar 200mg Powder for IV Injection, DR-XY40364
  • Humulin 70/30 Vial, DR-XY14545
  • Humulin N Vial, DR-XY6181
  • Humulin R Vial, DR-XY6180
  • Humulin 70/30 Cartridge, DR-XY23452
  • Humulin N Cartridge, DR-XY23454
  • Zyprexa 5mg Tablet, DR-XY22855
  • Zyprexa 10mg Tablet, DR-XY22856
  • Alimta 100mg Lyophilized Powder for Intravenous Infusion, DR-XY35204
  • Alimta 500mg Lyophilized Powder for I.V. Infusion, DR-XY31536
  • Gemzar 1g Powder for Injection, DR-XY42100
  • Cymbalta 60mg Capsule, DR-XY41867
  • Zyprexa Zydis 5mg Tablet, DR-XY37273
  • Forteo 250mcg/mL Solution for Injection, DR-XY29234
  • Byetta 250mcg/mL Solution for Injection (1.2mL) SC, DR-XY33256
  • Byetta 250mcg/mL Solution for Injection (2.4mL) SC, DR-XY33264
  • Effient 5mg Film-Coated Tablet, DR-XY37670
  • Effient 10mg Film-Coated Tablet, DR-XY37671
  • Cymbalta 30mg Capsule, DR-XY31173
  • Zyprexa Zydis 10mg Orodispersible Tablet, DR-XY37455

Earlier this month, the FDA fined the pharmaceutical firm P16 million for importing and distributing unregistered products.

FDA also ordered the recall of 15 Eli Lilly Philippines products after finding they were either unregistered or had falsified product registrations.

Covered by the recall order were:

  • Cialis 20 mg Tablet
  • Cymbalta 30mg Capsule
  • Humalog 100 units per mL Solution for Injection
  • Humalog Kwikpen 100u/mL Solution for Injection
  • Humalog Mix 25 Kwikpen 100iu per mL Solution For Injection
  • Humalog Mix 25
  • Humalog Mix 50 Kwikpen
  • Stratterra 10mg Capsule
  • Stratterra 18mg Capsule
  • Stratterra 25mg Capsule
  • Straterra 40 mg Capsule
  • Strattera 60mg Capsule
  • Prozac 20mg Capsule
  • Zyprexa Zydis 10mg Orodispersible tablet
  • Zyprexa Intramascular 20mg Powder for Injection

Dr. Kenneth Hartigan-Go, FDA director,  said at the time that only the following Eli Lilly products have a certificate of product registration:

  • Alimta 100mg Lyophilized Powder for Intravenous Infusion, FDA registration number DR-XY35204
  • Alimta 500mg Lyophilized Powder for I.V. Infusion, DR-XY31536
  • Gemzar 1g Powder for Injection, DR-XY42100
  • Cymbalta 60mg Capsule, DR-XY41867
  • Zyprexa Zydis 5mg Tablet, DR-XY37273
  • Forteo 250mcg/mL Solution for Injection, DR-XY29234
  • Byetta 250mcg/mL Solution for Injection (1.2mL) SC, DR-XY33256
  • Byetta 250mcg/mL Solution for Injection (2.4mL) SC, DR-XY33264
  • Effient 5mg Film-Coated Tablet, DR-XY37670
  • Effient 10mg Film-Coated Tablet, DR-XY37671

The FDA advised the public to email for inquiries. Those who want to report unregistered health products and adverse reactions after using any health product may email the FDA. Joel Locsin/JDS, GMA News

Friday, May 30, 2014

Washington Post: Five Myths About the Triple Crown--One of those Myths is that Doping has tarnished the Triple Crown Series

John Scheinman, a former horse racing reporter for The Washington Post, is a freelance writer and editor. He contributes to the Blood-Horse, Thoroughbred Racing Commentary, Bleacher Report and other publications.  In the Washington Post Scheinman address his thoughts on whether doping has tarnished the Triple Crown and states:
 
3. Doping has tarnished the Triple Crown series.
The racing world at times has been awash in scandal and derision over medication and doping issues.
Yet elaborate security protocols were developed by state racing commissions for horses running in the Triple Crown following the death of the filly Eight Belles in the 2008 Kentucky Derby.
These days, the Triple Crown horses practically live in maximum-security prisons. State racing commission security at their stalls runs around the clock. Multiple blood samples are taken in the days leading up to the races and are examined in specialized labs. Vet records are monitored. Commission investigators or vets oversee the administration of all medications. Vials and syringes are taken by the commissions for possible testing. Entry and exit logs are kept to follow who goes in and out of the barns. Security cameras are in place. Post-race testing is also conducted. If anyone is cheating under such heavy scrutiny, they’re doing a damn good job of it.

quoted from here

Iowa Board of Pharmacy 2014 Annual Meeting scheduled for June 13-14

2014 Annual Meeting
5/27/2014

The 2014 Annual Meeting will be
The 2014 Annual Meeting will be held June 13-14 at Prairie Meadows Conference Center in Altoona.
 
 
 
 

Practical Implications of the Final Omnibus Rule’s Electronic Access Provisions: Are Providers Required to Email ePHI to Patients?

Practical Implications of the Final Omnibus Rule’s Electronic Access Provisions: Are Providers Required to Email ePHI to Patients?


Vol. 10 No. 9


Anesthesiology News - ‘Survival of the Fittest’ for Outsourcing Facilities

Anesthesiology News - ‘Survival of the Fittest’ for Outsourcing Facilities

May 30, 2014, 12:42 p.m. EDT

In CompoundingToday.Com Newsletter May 30, 3014 Dr. Loyd Allen includes a list of how compouders save lives everyday. Be sure and check out his list.

Texas Board of Pharmacy Announces Schedule for September 2014-August 2015







TEXAS STATE BOARD OF PHARMACY

FY2015 CALENDAR OF EVENTS


(September 1, 2014 – August 31, 2015) SEPTEMBER 2014
1 LABOR DAY – STATE HOLIDAY – Office Closed (Monday)
25-26 Rosh Hashanah – Optional Holiday (Thursday - Friday)**
OCTOBER 2014
NOVEMBER 2014
4 TSBP BOARD BUSINESS MEETING, Austin, TX
4 Election Day (Tuesday)
11 VETERANS DAY – STATE HOLIDAY – Office Closed (Tuesday)
27 THANKSGIVING DAY – STATE HOLIDAY – Office Closed (Thursday)
28 THANKSGIVING HOLIDAY – STATE HOLIDAY – Office Closed (Friday)
DECEMBER 2014
24 CHRISTMAS EVE – STATE HOLIDAY – Office Closed (Wednesday)
25 CHRISTMAS DAY - STATE HOLIDAY – Office Closed (Thursday)
26 CHRISTMAS HOLIDAY - STATE HOLIDAY – Office Closed (Friday)
JANUARY 2015
1 NEW YEAR’S DAY - STATE HOLIDAY – Office Closed (Thursday)
19 MARTIN LUTHER KING, JR. DAY & CONFEDERATE HEROES DAY
STATE HOLIDAY – Office Closed (Monday)
FEBRUARY 2015
3-4 TSBP BOARD BUSINESS MEETING, Austin, TX
16 PRESIDENT’S DAY - STATE HOLIDAY – Office Closed (Monday)
MARCH 2015
2 Texas Independence Day - Skeleton Holiday – Office Open (Monday)*
31 Cesar Chavez Day – Optional Holiday (Tuesday)**
APRIL 2015
3 Good Friday – Optional Holiday (Friday)**
21 San Jacinto Day – Skeleton Holiday – Office Open (Tuesday)
continue to read schedule here

Colorado Board of Pharmacy Minutes for March 20, 2014 Meeting--including decision to vote to bring action against Precision and Village Fertility Pharmacy

COLORADO STATE BOARD OF PHARMACY Minutes

cdn.colorado.gov/cs/Satellite?blobcol=urldata&blobheadername1... · 11 hours ago
Pharmacy Board Minutes March 20, 2014 2 • Rule 6.00.30– The Board voted unanimously to move the proposed language to a public rulemaking hearing.

Nevada Board of Pharmacy Helps uncover Fraudulent medical offices uncovered in Las Vegas

Fraudulent medical offices uncovered in Las Vegas

Maine Board of Pharmacy Enters into Consent Agreement Dated 5/20/2014 with Prescription Corporation of Amercia

05/20/20142013-PHA-9491PRESCRIPTION CORPORATION OF AMERCIAMO40001304MAIL ORDER PHARMACYCONSENT AGREEMENT

Maine Board of Pharmacy Tenative Agenda for June 5, 2014 Meeting

view agenda here

Iowa Board of Pharmacy Minutes from March 10-12, 2014 Meeting--including memos denying several license to non-resident pharmacies

March 10-12, 2014Minutes

Indiana State Board of Pharmacy Disciplinary Action and Complaints for 2014--Including The Drug Store and Custom Med Apothecary

Last NameFirst NameMILicenseBoardDateType
Freiberger J Lynne 26011641A Indiana State Board of Pharmacy 05/02/2014 Complaint 118k
Freiberger J Lynne 26011641A Indiana State Board of Pharmacy 05/05/2014 Motions 53k
Way William Z 26012430A Indiana State Board of Pharmacy 04/02/2014 Complaint 398k
Day Stephen 26013076A Indiana State Board of Pharmacy 03/21/2014 Complaint 293k
Wilcox Rachel E 26014872A Indiana State Board of Pharmacy 05/09/2014 Complaint 302k
Northrop Susan 26016401A Indiana State Board of Pharmacy 05/21/2014 Findings of Fact and Order 122k
Adams Shannon 26019548A Indiana State Board of Pharmacy 03/11/2014 Findings of Fact and Order 55k
Quackenbush-Siders Rebecca R 26019601A Indiana State Board of Pharmacy 04/29/2014 Complaint 91k
Bachman Jared 26021573A Indiana State Board of Pharmacy 04/29/2014 Complaint 68k
Junker Keith 26021773A Indiana State Board of Pharmacy 05/21/2014 Findings of Fact and Order 123k
Sharp Noah 26025454A Indiana State Board of Pharmacy 03/27/2014 Board issued probation from application/renewal 82k
Sharp Noah L 26025454A Indiana State Board of Pharmacy 03/27/2014 Board issued probation from application/renewal 82k
Van Wye Benjamin 45017143A Indiana State Board of Pharmacy 04/17/2014 Board issued probation from application/renewal 98k
Collar Jonathan 45017229A Indiana State Board of Pharmacy 04/17/2014 Board issued probation from application/renewal 96k
Smith Adam 45018517A Indiana State Board of Pharmacy 04/17/2014 Board issued probation from application/renewal 97k
Patel Rohit 45018640A Indiana State Board of Pharmacy 04/17/2014 Board issued probation from application/renewal 156k
The Drug Store Inc 60002372A Indiana State Board of Pharmacy 05/02/2014 Complaint 98k
The Drug Store Inc 60002372A Indiana State Board of Pharmacy 05/05/2014 Motions 52k
Custom Med Apothecary Indianapolis 60005496A Indiana State Board of Pharmacy 03/13/2014 Findings of Fact and Order 74k
Drake Deborah J 67001610A Indiana State Board of Pharmacy 03/11/2014 Findings of Fact and Order 155k
Worthington Karrie A 67008344A Indiana State Board of Pharmacy 05/13/2014 Complaint 306k
Shead Donnielle 67008613A Indiana State Board of Pharmacy 05/21/2014 Findings of Fact and Order 112k
Kaminski Jaclyn 67009502A Indiana State Board of Pharmacy 03/11/2014 Findings of Fact and Order 56k
Huff Colin A 67018656A Indiana State Board of Pharmacy 04/29/2014 Complaint 72k
Akers Kelly L 67019040A Indiana State Board of Pharmacy 03/12/2014 Notice of Proposed Default 49k
Akers Kelly L 67019040A Indiana State Board of Pharmacy 03/13/2014 ES Order 51k
Akers Kelly L 67019040A Indiana State Board of Pharmacy 04/22/2014 Findings of Fact and Order 141k
Barrett Kathryn L 67021737A Indiana State Board of Pharmacy 04/29/2014 Complaint 59k
Jacks Whitney 67022204A Indiana State Board of Pharmacy 03/13/2014 ES Order 73k
Jacks Whitney 67022204A Indiana State Board of Pharmacy 04/02/2014 Complaint 262k
Miles Lisa 67023118A Indiana State Board of Pharmacy 03/12/2014 Notice of Proposed Default 49k
Miles Lisa 67023118A Indiana State Board of Pharmacy 03/13/2014 ES Order 56k
Miles Lisa 67023118A Indiana State Board of Pharmacy 04/22/2014 Findings of Fact and Order 155k
Indiana Respiratory Service LLC 69000070A Indiana State Board of Pharmacy 04/29/2014 Complaint 54k
Toler Nicole 99061201A Indiana State Board of Pharmacy 03/13/2014 Board issued probation from application/renewal 79k
Heffernan Ellie 99061640A Indiana State Board of Pharmacy 04/17/2014 Board issued probation from application/renewal 172k
Nordeen Nichole 99061641A Indiana State Board of Pharmacy 04/17/2014 Board issued probation from application/renewal 154k
Graham Kristen 99061642A Indiana State Board of Pharmacy 04/17/2014 Board issued probation from application/renewal 156k

FDA Enforcement

Drugs REUMOFAN PLUS Tablets, 30 Tablet Bottles, OTC. Previene el cancer en los huesos, Nueva presentacion el original. All lots Class I Marketed Without an Approved NDA/ANDA; Product contains undeclared diclofenac and methocarbamol. Pain Free By Nature
Drugs GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP, 5mg/500mg, 500 count bottle, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC: 0093-5712-05 TE36018, Exp. 06/15 Class II CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements Teva Pharmaceuticals USA
Drugs INDOMETHACIN Capsules USP, 25 mg 100 count bottle, Rx only , Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4029-01 TE32134, Exp. 02/15 Class II CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements Teva Pharmaceuticals USA
Drugs INDOMETHACIN Capsules USP, 50 mg, a) 100 count bottle, (NDC 0093-4030-01), b) 500 count bottle, (NDC 0093-4030-05), Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960 TE38139, Exp. 08/16, TE39022, Exp. 09/16, Class II CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements. Teva Pharmaceuticals USA
Drugs METHYLDOPA Tablets USP, 500 mg, 100 count bottle, Rx only, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-2932-01 TE36053A,TE36063A, Exp. 06/16 Class II CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements Teva Pharmaceuticals USA
Drugs Smart Tab First Aid ezRefill System Ibuprofen dispenser boxes (Item Number FAE 7014), 20 count boxes, First Aid Only Inc., Vancouver, WA Aspirin was packed into Ibuprofen boxes (Item Number FAE-7014) coded: B11340515, B11840515, B12040615, B12540615, B12640615, B12740615, C10340615 and B11040516. Class II First Aid Only, Inc is recalling Smart Tab First Aid ezRefill System Ibuprofen boxes and First Aid Cabinets containing these Ibuprofen boxes. Ibuprofen boxes (FAE 7014) were accidentally used to package aspirin packs (10 packs of 2 / 235mg tablets). First Aid Only Inc
Drugs PSYLLIUM FIBER, Laxative/Supplement, 100 Capsules, OTC. Manufactured By: Konsyl Pharmaceuticals, Inc., Easton, MD 21601. NDC: 0224-1847-10. Lot #: A44701 (expiry: 07/16) , A44701C (expiry: 07/16), J34701C-1 (expiry: 07/16) Class III Labeling: Label Error on Declared Strength; Listed active ingredient strength is inaccurate. Konsyl Pharmaceuticals Inc
Drugs Laroscorbine Platinium (vitamin C/collagen) injectable I.V. solution, 1 gm/0.35 gm, 5 mL ampoules, packaged in 10-count ampoules per box, Laboratories Roche Nicholas S.A., F-74240 Gaillard, - Tel.: 04 50 87 70 70, Fabricant : Produits Roche, 52, Bld du Parc, 92521 Neulilly -sur-Seine Cedex, barcode *3421357* Lot #: F040, Exp 08/16 Class II Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote. Flawless Beauty LLC
Drugs Tatiomax (reduced glutathione/hydrolyzed collagen) powder for injection vials, 1200 mg/200 mg, 10-count vials per box, Manufactured by: Sujie Pharmaceutical Ltd., Tokyo, Japan, UPC 4973430081576 Lot #: UB302, Exp 05/12/15 Class II Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote. Flawless Beauty LLC
Drugs Saluta (reduced glutathione) Powder for Injection, 600 mg/vial, packaged in 10 vials per box, Exclusively Distributed by: QAF Pharmaceuticals Inc. Philippines, Unit Unit 202 ECG Building, Multinational Avenue, Multinational Village, Parahaque City, Metro Manila Philippines; Manufactured by: Shandong Luye Pharmaceutical Co. Ltd, Yantai Shandong, PRC la Luye Pharma Subsidiary, UPC 6920425209014 Lot #: 201302275, Exp 01/20/15; 201308384, Exp 10/19/2015 Class II Marketed Without An Approved NDA/ANDA: Parenteral product is labeled for use as an antidote. Flawless Beauty LLC
Drugs Relumins Advanced Glutathione (lyophilized glutathione/vitamin C) injectable solution, 1500 mg/500 mg, packaged in 8-count vials, 8-count 5 mL vitamin C (ascorbic acid) solution diluent ampoules, and 30-count Advanced Glutathione Boosters capsules per box, Relumins Labs, 183 Locust Avenue, West Long Branch, NJ 07764, UPC 700175760302 Lot #: 130616, Exp 06/16 Class II Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used parenterally for drug claims. Flawless Beauty LLC
Drugs Vitamin C (ascorbic acid) Injection, USP, 500 mg per 2 mL, 50 x 2 mL ampoules per box, Manufactured by: TP Drug Laboratories (1969) Co., Ltd., 98 Soi Sukhumvlt 62, Yak 1, Bangchak, Prakanong, Bangkok 10260, Thailand, Reg. No. 1 A 1557/30; UPC 8 853533 000533 Lot #: 556273, Exp 9/25/16; 556219, Exp 8/2/16, or any other lot distributed by Flawless Beauty. Class II Marketed Without An Approved NDA/ANDA: Parenteral product is sold over the counter whose labeling indicates it is to be used for the treatment of disease. Flawless Beauty LLC
Drugs Sterile Water for Injection, 5 mL ampoules, packaged in 50-count ampoules per box, Manufactured and Distributed by: Euro Med Laboratories, UPC 4800573016219 Lot #: 16U394, Exp 04/16; 16U421, Exp 08/16; 16U423, Exp 09/16 Class II Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used for parenteral injection. Flawless Beauty