Drug and pharmaceutical recalls
17728 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2018-11-07FDA-DrugSprayologyClass IIWoman Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879 NDC 61096-0034-1 and Tester NDC 61096-1034-1
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
- 2018-11-07FDA-DrugSprayologyClass IIBrain Power,Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0033-1
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
- 2018-11-07FDA-DrugSprayologyClass IIMan Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0025-1 and Tester NDC 61096-1025-1
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
- 2018-11-07FDA-DrugSprayologyClass IIRejuvenation Plus, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879 NDC 61096-0035-1
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
- 2018-10-31FDA-DrugUpsher Smith Laboratories, Inc.Class IIBumetanide Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0542-11
Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
- 2018-10-31FDA-DrugUpsher Smith Laboratories, Inc.Class IIBumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0541-11
Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
- 2018-10-31FDA-DrugPromise Pharmacy LLCClass IIIPrednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only, 31818 US Hwy 19N, Palm Harbor, FL 34684
Presence of precipitate
- 2018-10-31FDA-DrugRXQ Compounding LLCClass IILidocaine 1% + Epinephrine 1:100,000 (MDV) INJ SOL, 50 mL per glass vial, Rx only, 340 West State Street, Unit 9, Athens, OH 45701. NDC 7073197450
Subpotent drug: During testing of the retention sample, the firm discovered that the product was sub-potent.
- 2018-10-31FDA-DrugTeva Pharmaceuticals USAClass IIMetoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 62037-831-01
Failed dissolution specifications: Out-of-Specification dissolution test result obtained during routine stability testing.
- 2018-10-31FDA-DrugTeva Pharmaceuticals USAClass IIPIO&METFORMIN 15/1000 mg Tab 1 (Pioglitazone and Metformin XT) tablets, Takeda Brand Name: Actoplus Met XR (Pioglitazone and metformin HCl extended -release) tablets, 15 mg/1000 mg, packaged in a fiber drum, Application Holder Takeda Pharmaceuticals, U.S.A. Inc. One Takeda Parkway, Deerfield, IL 60015
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
- 2018-10-31FDA-DrugTeva Pharmaceuticals USAClass IIMetformin Hydrochloride Extended Release Tablets 1000 mg, 90-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL, 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 , NDC 00591-2412-19
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
- 2018-10-31FDA-DrugTeva Pharmaceuticals USAClass IIMetformin Hydrochloride Extended Release Tablets 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL, 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 , NDC 00591-2720-60
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
- 2018-10-31FDA-DrugTeva Pharmaceuticals USAClass IIMetformin Hydrochloride Extended Release Tablets, 500 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories, FL Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 00591-2411-01
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
- 2018-10-31FDA-DrugTeva Pharmaceuticals USAClass IIFortamet (metformin HCl) extended release tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Shionogi Inc., Florham Park, NJ 07932, NDC 59630-575-60
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
- 2018-10-31FDA-DrugTeva Pharmaceuticals USAClass IIPaliperidone Extended Release Tablets 9 mg, packaged in a) 30-count bottle(NDC 0591-3695-30) , b) 90-count bottle (NDC 0591-3695-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
- 2018-10-31FDA-DrugTeva Pharmaceuticals USAClass IIPaliperidone Extended Release Tablets 3 mg, packaged in a) 30-count bottle(NDC 0591-3693-30), b) 90-count bottle (NDC-0591-3693-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
- 2018-10-31FDA-DrugPfizer Inc.Class IIMeropenem for Injection, USA (I.V.), 1 gram/vial, 25 vials per carton, Sterile, Rx Only, Manufactured for: Hospira, Inc., Lake Forest, IL 60045, USA. NDC carton: 0409-3506-01; NDC vial: 0409-3506-11
Lack of assurance of sterility: loss of container integrity.
- 2018-10-31FDA-DrugHeritage Pharmaceuticals, Inc.Class IICidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only, Mfg. By Emcure Pharmaceutical Ltd Hinjawadi, Pune, India, Mfg for: Heritage Pharmaceuticals Inc. UPC 323155216388, NDC 23155-216-31
Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle
- 2018-10-31FDA-DrugRemedyRepack Inc.Class IIAmlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in cardboard trays Original NDC 13668-0325-30 Repackaged NDC 70518-1220-00
CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
- 2018-10-31FDA-DrugLUPIN SOMERSETClass IIFluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, MD 21202 Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-069-60
Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis
- 2018-10-31FDA-DrugWestlab Pharmacy, Inc. dba Westlab PharmacyClass IICyclosporine 1% Human Eye Drops, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-2776-92
Lack of Process Controls
- 2018-10-31FDA-DrugWestlab Pharmacy, Inc. dba Westlab PharmacyClass IIADAA Cataract Drops, (Lido 1.47%, Phenyleph 0.294% Cyclopentolate 0.147%, Tropicamide 0.0735%, Moxiflox 0.0294%, Ketorolac 0.0147%) 1x 1cc syringe, Westlab Pharmacy, Inc., Gainesville, FL 32607 --- NDC 10002-2579-05
Lack of Process Controls
- 2018-10-31FDA-DrugWestlab Pharmacy, Inc. dba Westlab PharmacyClass IIAlprostadil 500 mcg/mL Injectable, Vials, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-7335-00
Incorrect Product Formulation
- 2018-10-31FDA-DrugLupin Pharmaceuticals Inc.Class IIITestosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 INDIA, NDC 68180-943-11
Defective Container: Repetitive complaints received indicating pump not working.
- 2018-10-31FDA-DrugValeant Pharmaceuticals North America LLCClass IICortaid 12-Hour Advanced Anti-itch Cream (1% hydrocortisone), NET WT 1.5 oz. (42 g) tube, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875519155
CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.
- 2018-10-31FDA-DrugValeant Pharmaceuticals North America LLCClass IICortaid Maximum Strength Cream (1% hydrocortisone), 1 OZ (28 g) tube, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875521011
CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.
- 2018-10-31FDA-DrugValeant Pharmaceuticals North America LLCClass IICortaid Intensive Therapy Cooling Spray (1% hydrocortisone), 2 FL OZ (59 mL) spray bottle, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875518028
CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.
- 2018-10-31FDA-DrugLannett Company, Inc.Class IIHydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP), 10 mg per 5 mL, Rx only, Distributed by Lannett Company, Inc., Philadelphia, PA 19154, NDC 54838-502-80.
CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.
- 2018-10-24FDA-DrugAmerigen Pharmaceuticals Inc.Class IIITemozolomide capsules, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05), b) 14-count bottle (NDC 43975-253-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071.
Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing.
- 2018-10-24FDA-DrugTeva Pharmaceuticals USAClass IIClonazepam Orally Disintegrating Tablets USP, 2 mg., 60-count carton. RX only. Teva Pharmaceuticals USA, INC. North Whales, PA 19454. NDC 0555-0098-96
Failed Stability Specifications: Out-of-specification test result for water content obtained during routine stability testing.
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