FDA Enforcement Report: Fresenius Kabi USA, LLC; Micro Labs Limited, etc.

DrugsHALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC 63323-469-01Lot 6105149, Exp.05/14; 6105696, Exp. 07/14; 6105836, Exp. 08/14; Lot 6106501, Exp. 12/14; Lot 6106837, Exp. 02/15Class IIIFailed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result.Fresenius Kabi USA LLCDrugsFLUOCINONIDE GEL USP, 0.05%, Rx only, For External Use Only, Not For Ophthalmic Use, a) NET WT 15 gram tubes and b) NET WT 60 grams tubes, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0135-15 (15 g) and NDC 0168-0135-60 (60 g)a) 15 gram lot numbers: 549N, 550N,551N Exp. 1/2015, EB1961, Exp. 2/2017; b) 60 gram lot numbers: 546N, 547N, 548N, Exp. 1/2015, EB0144, Exp. 2/2017Class IIFailed Stability Specifications: The lots of Fluocinonide Gel USP, 0.05% recalled, may not meet the requirements for residual solvents as outlined in USP <467>.Fougera Pharmaceuticals Inc.DrugsSimvastatin Tablets, USP, 10 mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited, Goa-403 722, INDIA, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540, NDC 42571-010-90Lot #: STBG005, Exp 2/2015Class IIIFailed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy Anisole Content) against shelf life specification.Micro Labs Usa, Inc SDrugsAssured Naproxen Sodium Tablets, USP 220 mg., 15 count bottle, Repackaged by Contract Packaging Resources, Inc 8009 Industrial Village Road Greensboro, NC 27409 Distributed by Greenbrier International, Inc Chesapeake, VA 23320Lot FH4102A UPC #639277223685, Exp. Date 3/16Class IICorrect Labeled Product Mispacked; correct labeled bottles of Assured Ibuprofen softgels were packaged into boxes of Assured Naproxen Sodium Tablets, USPContract Packaging Resources Inc.

quoted from November 19, 2014 FDA enforcement report