Drug and pharmaceutical recalls
17628 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2016-10-19FDA-DrugTeva Pharmaceuticals USAClass IIAmikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9032-01 (individual pack), NDC 0703-9032-03 (shelf-pack carton of 10 vials).
CGMP Deviations
- 2016-10-19FDA-DrugThe Harvard Drug GroupClass IDiocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint (473 mL) bottles, Dist by: Rugby Laboratories, Livonia, MI --- NDC 0536-0590-85
Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia
- 2016-10-19FDA-DrugBee XtremeClass IJenesis Dietary Supplement Capsules, 350 mg, 60 count bottles, Manufactured for Timeless Solutions, 1810 E Sahara Ave #100, Las Vegas, Nevada 89104, distributed by BeeXtreme LLC, Punxsutawney PA
Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein
- 2016-10-19FDA-DrugBee XtremeClass IOasis Dietary Supplement Capsules, 500 mg, 45 count bottles, Manufactured for Timeless Solutions, 1810 E Sahara Ave #100, Las Vegas, Nevada 89104, distributed by BeeXtreme LLC, Punxsutawney PA
Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein
- 2016-10-19FDA-DrugBee XtremeClass ILa' Trim Plus Dietary Supplement Capsules, 350 mg, 60 count bottles, Manufactured for Timeless Solutions, 1810 E Sahara Ave #100, Las Vegas, Nevada 89104, distributed by BeeXtreme LLC, Punxsutawney PA
Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein
- 2016-10-19FDA-DrugLeiter's CompoundingClass IIVancomycin 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-005-35
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
- 2016-10-19FDA-DrugLeiter's CompoundingClass IIPlacebo for Prednisolone Acetate 1%, Oph Suspension, 10 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
- 2016-10-19FDA-DrugLeiter's CompoundingClass IIMoxifloxacin 1 mg/mL in Sterile Balanced Salt Solution (BSS) Intravitreal Injection, 1 mL Total Volume in a 2 mL Vial, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-003-35
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
- 2016-10-19FDA-DrugLeiter's CompoundingClass IIMitomycin 0.02% (0.2 mg/mL) in Sterile Water for Injection (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-005-35
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
- 2016-10-19FDA-DrugLeiter's CompoundingClass IILidocaine HCl 1% - Phenylephrine HCl 1.5% in Sterile Water for Injection (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-002-35
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
- 2016-10-19FDA-DrugLeiter's CompoundingClass IICyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5% in Sterile Water for Injection (Ophthalmic Solution), in a) 1 mL Total Volume (NDC 70360-017-38) and b) 10 mL Total Volume (NDC 70360-017-39) in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-017-38
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
- 2016-10-19FDA-DrugLeiter's CompoundingClass IICefuroxime Sodium 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-007-35
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
- 2016-10-19FDA-DrugLeiter's CompoundingClass IIBrilliant Blue G 0.025% in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-008-35
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
- 2016-10-19FDA-DrugLeiter's CompoundingClass IIAtropine Sulfate 0.01% in 0.9% Sodium Chloride (Ophthalmic Solution) 10 mL Total Volume in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-011-39
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
- 2016-10-19FDA-DrugAmerisource Health ServicesClass IIIParicalcitol Capsules, 1 mcg, packaged in 30 Capsules (5 x 6) per carton (NDC 60687-106-25); each blister card containing 6 individually blistered capsules (NDC 60687-106-95), Rx only, Distributed by: American Health Packaging, Columbus, OH, 43217.
Failed Impurities/Degradation Specifications: This repackaged product was recalled by its manufacturer due to failed results for impurities.
- 2016-10-12FDA-DrugWest-Ward PharmaceuticalClass IIPredniSONE Tablets USP, 1 mg, 100-count bottles, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC 0054-4741-25.
Failed Tablet/Capsule Specifications: Discovery of an underweight tablet.
- 2016-10-12FDA-DrugSun Pharmaceutical Industries, Inc.Class IIIbuPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, Twice-A-Day, in 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by Sun Pharmaceuticals Ind. Ltd. Halol- Baroda Highway, Halol-389 350, Gujarat, India. UPC 347335737868 NDC 47335-737-86
Failed Dissolution Specifications
- 2016-10-12FDA-DrugShireClass IIIVyvanse (lisdexamfetamine dimesylate) Capsules 30 mg, 100 count bottle, Rx Only, Manufactured for: Shire US, Inc., Lexington, MA 02421, NDC 59417-103-10
Presence of Foreign Tablets/Capsules
- 2016-10-12FDA-DrugTeva North AmericaClass IIIClaravis (isotretinoin capsules USP), 10mg, packaged in carton containing 3 Blister Packs of 10 Capsules Each (30 Capsules total); Rx only, TEVA PHARMACEUTICALS USA, Sellersville, PA 18960. NDC 00555-1054-86
Failed Impurities/Degradation Specifications.
- 2016-10-12FDA-DrugThe Apothecary Shoppe LLCClass IITri-Mix 18/1/10 (Papaverine 18mg, Phentolamine 1 mg, Prostaglandin 10 mcg/mL) packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK
Lack of Assurance of Sterility; medication was sterilized with a recalled filter
- 2016-10-12FDA-DrugThe Apothecary Shoppe LLCClass IIPhenotolamine 0.4mg/Prostaglandin 20mcg/mL packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK
Lack of Assurance of Sterility; medication was sterilized with a recalled filter
- 2016-10-12FDA-DrugThe Apothecary Shoppe LLCClass IIStop using The Apothecary Shoppe methylcobalamin injection
Lack of Assurance of Sterility; medication was sterilized with a recalled filter
- 2016-10-12FDA-DrugBiocompatibles U.K., Ltd.Class IIIDo not use Varithena administration pack
Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack
- 2016-10-05FDA-DrugMckesson Packaging ServicesClass IIILansoprazole Delayed-Release Capsules, USP, 30 mg, packaged in 100-count cartons of 10 x 10 unit dose blister cards, Rx only, Manufactured by: Dr. Reddy's Laboratories, Inc., 200 Somerset Corporate Blvd Floor 7, Bridgewater, NJ 08807, NDC 63739-0555-10
Labeling: Label mix-up. The inner packaging was properly labeled Omeprazole DR 40mg Capsules, but the outer secondary packaging was mislabeled Lansoprazole Delayed-Release 30mg Capsules.
- 2016-10-05FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIDMSO 50% with Lidocaine 0.5%, 50ml SDV, Sterile, Rx, Vital Care Compounder, Hattiesburg, MS
Lack of Assurance of Sterility
- 2016-10-05FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIHyaluronidase, 150 u/ml, 10 ml SDV, Vital Care Compounder, Hattiesburg, MS 39402
Lack of Assurance of Sterility
- 2016-10-05FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIC-PAP/PHEN/PROST/Atrop 150/7.5 (Papaverine 150mg/Phentolamine 7.5mg/Prostaglandin 75mcg/Atropine 1mg injection), 10 ml vial containing 5.9ml solution, Rx, Vital Care Compounder, Hattiesburg, MS
Lack of Assurance of Sterility
- 2016-10-05FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIOlopatadine 0.8% Ophthalmic Solution, 3ml bottle, Rx, Vital Care Compounder, Hattiesburg, MS
Lack of Assurance of Sterility
- 2016-10-05FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIC-PAP/PHEN/PROST/ATROP 150/5/5 (Papaverine 150mg/Phentolamine 5mg/Prostaglandin 50mcg/Atropine 0.04mg injection), Rx, 10 ml vials contain 5.8 ml solution, Vital Care COMPOUNDER, Hattiesburg, MS 39402
Lack of Assurance of Sterility
- 2016-10-05FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIHydroxyzine HCl, 50mg/ml Inj, 10ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS
Lack of Assurance of Sterility
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