Drug and pharmaceutical recalls
17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 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.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIFamily Dollar Saline Nasal Spray 4.25 oz. can, 24 pk, SKU 0900562.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIFinafta Baby, Oral Gel (benzocaine 7.5%), 7.1 Grams (0.25 Oz.) tube, Distributed By: Efficient Laboratories, Inc., Miami, FL 33166.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIRexall, Extra Moisturizing No Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) 1 FL OZ (30 mL) bottle, 48 pk. (12687901)
CGMP Deviations: products manufactured under conditions that could impact its product quality.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIRexall, Extra Moisturizing No Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) 1 FL OZ (30 mL) bottle, 48/3/1 #12687901 w/ Silo
CGMP Deviations: products manufactured under conditions that could impact its product quality.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIRexall, Sinus Nasal Pump Mist, (Oxymetazoline Hydrochloride 0.05%), 1 FL OZ (30mL) bottle, SKU 00744201
CGMP Deviations: products manufactured under conditions that could impact its product quality.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIRhinall Nasal Decongestant Nasal Spray (phenylephrine HCl), 0.25%, 1 1/3 Fl Oz. (40 ml), Manufactured for: Scherer Laboratories, Inc., Atlanta, GA 30339.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass ISinus Relief (oxymetazoline HCl) Nasal decongestant, 0.05%, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 43236 5.
Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Pseudomonas aeruginosa.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IICVS Health, Original Strength, Triple Antibiotic Ointment Spray (bacitracin zinc 400 units, neomycin sulfate 3.5 mg, polymyxin B sulfate 5,000 units per gram), 2 OZ (57 g) can, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Product#957603, UPC 0 50428 29525 0.
Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIMushatt's No. 9, PsoriWash Medicated Wash, Salicylic Acid 1.8%, 8 oz. (226 g) tube, Distributed by Mushatts, LLC, P.O. Box 372476, Satellite Beach, FL 32937, UPC 8 58245 00203 3.
Microbial Contamination of Non-Sterile Products and Subpotent Drug: failure for microbiological growth exceeding specification and low out of specification assay results for salicylic acid.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IICeraVe Healing Lip Balm/SPF 30 (avobenzone 3%, dimethicone 1%, homosalate 10%, octisalate 5%, octocrylene 10%, Net Wt. 0.15 oz. (4.25 g) stick, CeraVe LLC., New York, NY 10001, UPC 3 01872 49201 7.
Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Staphalococcus aureus.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIICicatricure, Scar Cream + Sunscreen SPF 30 (avobenzone 3%, octocrylene 10%, oxybenzone 6%), 0.7 oz. (19.8 g) tube, Distributed by: Genomma Lab USA Inc., Houston, TX 77027, UPC 6 50067 00018 7.
Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIIWell at Walgreens, Scar Cream with SPF 30, (Avobenzone 3%, Octocrylene 10%, Oxybenzone 6%), 0.7 OZ (19.8 g) tube, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, UPC 3 11917 18281 0.
Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIPremier Value, Fast Relief, Muscle Rub, (menthol 10% and methyl salicylate 15%) 4 OZ (113 g) tube, Distributed By: Chain Drug Consortium, 3301 NW Boca Raton Blvd., Suite 101, Boca Raton, FL, 33431, UPC 8 40986 01341
Superpotent Drug: high out of specification assay results for the menthol ingredient.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIRite Aid Pharmacy, First Aid Antibiotic Ointment, (neomycin sulfate 3.5 mg, polymyxin B sulfate 5,000 units, bacitracin zinc 400 units per gram), 2 OZ (56 g) tube, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, UPC 0 11822 55441 1.
Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient.
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