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.
- 2022-08-17FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IIGenTeal Tears, Lubricant Eye Ointment, Night-Time Ointment, Sterile, 3.5 gm (0.12 FL OZ) per box, Alcon, NDC 0065-0518-01.
CGMP Deviations: products were stored outside the drug label specifications.
- 2022-08-17FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IIMiralax (Polyethylene Glycol 3350), Powder for Solution, Osmotic Laxative, 30 Once-Daily Doses, Net WT 17.9 OZ (510 g) bottle, Bayer Healthcare Pharmaceuticals, NDC 11523-7234-4.
CGMP Deviations: products were stored outside the drug label specifications.
- 2022-08-17FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IIDebrox, Carbamide Peroxide, Earwax Removal Aid, 0.5 FL OZ (15 mL) bottle per box), MedTech Products Inc., NDC 63029-321-01.
CGMP Deviations: products were stored outside the drug label specifications.
- 2022-08-17FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IISystane Zaditor, ketotifen fumarate ophthalmic solution 0.035%, Antihistamine eye drops, Eye Itch Relief, up to 12 Hours, Sterile, 30 day supply, 5mL (0.17 FL OZ) bottle per box, Alcon, NDC 0065-4011-05.
CGMP Deviations: products were stored outside the drug label specifications.
- 2022-08-17FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IISystane Balance, Lubricant Eye Drops, Propylene Glycol 0.6% lubricant, Restorative Formula, Sterile, 10 mL (1/3 FL OZ) bottle per box, Alcon, NDC 0065-1433-02.
CGMP Deviations: products were stored outside the drug label specifications.
- 2022-08-17FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IIEye-stream, eye wash solution, sterile, 4 FL OZ (118 mL) bottle per box, Alcon, NDC 0065-0530-04.
CGMP Deviations: products were stored outside the drug label specifications.
- 2022-08-17FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IISystane, Lubricant Eye Drops, Polyethylene Glycol 400 0.4% Lubricant, Propylene Glycol 0.3% Lubricant, Original, Long Lasting Dry Eye Relief, Sterile, a) 15 mL (0.5 FL OZ) NDC 0065-0429-15, b) 30 mL (1 FL OZ) NDC 0065-0429-30, bottle per box, Alcon Surgical Inc.
CGMP Deviations: products were stored outside the drug label specifications.
- 2022-08-17FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IINaphcon A eye drops, Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%, Redness Reliever and Antihistamine Eye Drops, Sterile, 15 mL (0.5 FL OZ) bottle per box, Alcon, a Novartis company, NDC 0065-0085-15.
CGMP Deviations: products were stored outside the drug label specifications.
- 2022-08-17FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IIBisacodyl Suppositories, Fast Acting Stimulant Laxative, 100 suppositories per box, 10 mg each, Health Star, NDC 57896-443-01.
CGMP Deviations: products were stored outside the drug label specifications.
- 2022-08-17FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IITriple Antibiotic Ointment, Bacitracin zinc, Neomycin sulfate, Polymixin B sulfate, First Aid Antibiotic, Triple Antibiotic Ointment, 144 packets per box, Net wt. per packet 0.5 g, Honeywell Safety Products, NDC 0498-0750-36.
CGMP Deviations: products were stored outside the drug label specifications.
- 2022-08-17FDA-DrugHikma Pharmaceuticals USA Inc.Class IILorazepam Injection, USP, 4mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC# NDC# 0641-6045-25, Vial NDC# 0641-6045-01
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
- 2022-08-17FDA-DrugHikma Pharmaceuticals USA Inc.Class IILorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC# 0641-6048-25, Vial NDC# 0641-6048-01
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
- 2022-08-17FDA-DrugHikma Pharmaceuticals USA Inc.Class IIAtivan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07724, Carton NDC# 0641-6001-25, Vial NDC# 0641-6001-01
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
- 2022-08-17FDA-DrugHikma Pharmaceuticals USA Inc.Class IILorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07724, Carton NDC# 0641-6044-25, Vial NDC# 0641-6044-01
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
- 2022-08-17FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IITelmisartan and Hydrochlorothiazide Tablets USP, 80 mg/12.5 mg, 30 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot no 2, Phase-2, Pharma Zone, SEZ Pithampur, District Dhar, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc,m USA, Mahwah, NJ 07430, NDC 68462-841-13.
Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .
- 2022-08-17FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IITelmisartan and Hydrochlorothiazide Tablets USP, 80 mg/25 mg, 30 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot no 2, Phase-2, Pharma Zone, SEZ Pithampur, District Dhar, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430, NDC 68462-842-13.
Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .
- 2022-08-10FDA-DrugUltra Supplement LLCClass ISUSTANGO (Pendenadril Tytrate Blend) Capsules, 400 mg, 10-count blisters per carton, Formulated by: Male FX Labs, Bangor, ME, ASIN X0024468I9.
Marketed Without an Approved NDA/ANDA: Analytical testing showed the presence of tadalafil.
- 2022-08-10FDA-DrugDistributor RFR, LLC.Class ISANGTER Energy Supplement Capsules, 3000mg x 7 grain, 7-count blister pack within a carton, Distributed by: Distributor RFR, LLC, (800) 519-0204 Miami 33172 FL, USA; UPC 0 705632 523285
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil.
- 2022-08-10FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IIITacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Use, Rx Only, a) 30 g tube, NDC 68462-534-35, b) 60 g tube, NDC 68462-534-65, c) 100 g tube, NDC 68462-534-94, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India.
Defective Container: Tube split from side seam
- 2022-08-10FDA-DrugTeva Pharmaceuticals USA IncClass IIMatzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30-count bottles, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL USA 33314, USA, Distributed by: Actavis Pharma Inc., Parsippany, NJ 07054 USA; NDC 58544-692-30.
Failed Dissolution Specifications: below specification limits for dissolution.
- 2022-08-10FDA-DrugTeva Pharmaceuticals USA IncClass IIMatzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 180 mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA; NDC 52544-691-30.
Failed Dissolution Specifications: below specification limits for dissolution.
- 2022-08-10FDA-DrugTolmar, Inc.Class IINaftifine Hydrochloride Gel, USP 1%, packaged in cartons with: a) Net Wt. 90g tube (NDC 0115-1510-48), b) Net Wt. 40g tube (NDC 0115-1510-63), c) Net Wt. 60g tube (NDC 0115-1510-58), Rx only, Manufactured by: Tolmar, Inc., Fort Collins, CO, 80526, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807
Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time
- 2022-08-03FDA-DrugPfizer Inc.Class IPropofol Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL per glass fliptop vial (NDC 0409-4699-54) further packaged in a tray of 10 vials (NDC Carton: 0409-4699-24), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA
Presence of particulate matter: particulate identified as a beetle.
- 2022-08-03FDA-DrugEco Lips, IncClass IIIJuice Beauty, The Organic Solution, SPF 8, Naturally Clear Lip Moisturizer, Hydratant pour les Levres, NET WT 0.15 oz (4.25 g) per tube, Active Ingredient: Zinc oxide 4%, Manufactured for Juice Beauty, Inc., 709 Fifth Ave., San Rafael, California 94901-3566
Failed Dissolution Specifications
- 2022-08-03FDA-DrugEco Lips, IncClass IIIJuice Beauty, The Organic Solution, SPF 8, Joyful Lip Moisturizer, Hydratant pour les Levres, NET WT 0.15 oz (4.25 g) per tube, Active Ingredient: Zinc oxide 4%, Manufactured for Juice Beauty, Inc., 709 Fifth Ave., San Rafael, California 94901-3566
Failed Dissolution Specifications
- 2022-08-03FDA-DrugJubilant Cadista Pharmaceuticals, Inc.Class IIIrbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-447-90
Failed Dissolution Specifications
- 2022-08-03FDA-DrugJubilant Cadista Pharmaceuticals, Inc.Class IIIrbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-448-90
Failed dissolution specifications.
- 2022-08-03FDA-DrugMylan Pharmaceuticals IncClass IInsulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens (NDC 49502-394-71), packaged in cartons of 5 prefilled pens (NDC 49502-394-75), Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 15317, Manufactured for: Mylan Specialty L.P., Morgantown, WV
Labeling: Missing label: Label missing from some prefilled pens.
- 2022-08-03FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IIDivalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol- 389 350, Gujarat, India, NDC 62756-798-88.
Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
- 2022-08-03FDA-DrugThe Procter & Gamble CompanyClass IIICrest 3D White Fluoride Anticavity Toothpaste, Advanced Triple Whitening, 0.243% sodium fluoride, Net Wt. 5.6 oz (158 g) a) Individual carton, UPC 0 37000 598534; b) 5-count Bundle, UPC 037000171867, Distributed. By Procter & Gamble, Cincinnati, OH 45202.
Labeling: Missing label: the product tube was missing a label and contained a different formulation.
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