💊

Drugs Recalls

Prescription and over-the-counter medications

17,302 Total Recalls

Cortaid 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

Valeant Pharmaceuticals North America

Class I - Dangerous

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.

Aug 24, 2018 Over-the-Counter View Details →

Meropenem 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

Pfizer

Class I - Dangerous

Lack of assurance of sterility: loss of container integrity.

Sep 20, 2018 Prescription Drugs Nationwide View Details →

Cidofovir 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

Heritage Pharmaceuticals

Class I - Dangerous

Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle

Oct 15, 2018 Prescription Drugs Nationwide View Details →

Lidocaine 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

RXQ Compounding

Class I - Dangerous

Subpotent drug: During testing of the retention sample, the firm discovered that the product was sub-potent.

Sep 25, 2018 Prescription Drugs Nationwide View Details →

Cyclosporine 1% Human Eye Drops, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-2776-92

Westlab Pharmacy, Inc.

Class I - Dangerous

Lack of Process Controls

Aug 10, 2018 Compounded Drugs Nationwide View Details →

Paliperidone 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

Teva Pharmaceuticals USA

Class I - Dangerous

Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.

Aug 6, 2018 Prescription Drugs View Details →

Cortaid Maximum Strength Cream (1% hydrocortisone), 1 OZ (28 g) tube, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875521011

Valeant Pharmaceuticals North America

Class I - Dangerous

Aug 24, 2018 Over-the-Counter View Details →

Metoprolol 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

Teva Pharmaceuticals USA

Class I - Dangerous

Failed dissolution specifications: Out-of-Specification dissolution test result obtained during routine stability testing.

Oct 19, 2018 Prescription Drugs Nationwide View Details →

ADAA 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

Westlab Pharmacy, Inc.

Class I - Dangerous

Lack of Process Controls

Aug 10, 2018 Compounded Drugs Nationwide View Details →

Metformin 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

Teva Pharmaceuticals USA

Class I - Dangerous

Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.

Aug 6, 2018 Prescription Drugs View Details →

Amlodipine/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

RemedyRepack

Class I - Dangerous

CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.

Aug 24, 2018 Prescription Drugs View Details →

Paliperidone 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

Teva Pharmaceuticals USA

Class I - Dangerous

Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.

Aug 6, 2018 Prescription Drugs View Details →

HydrOXYzine 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.

Lannett Company

Class I - Dangerous

CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.

Oct 11, 2018 Prescription Drugs Nationwide View Details →

Alprostadil 500 mcg/mL Injectable, Vials, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-7335-00

Westlab Pharmacy, Inc.

Class I - Dangerous

Incorrect Product Formulation

Aug 10, 2018 Compounded Drugs Nationwide View Details →

Fortamet (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

Teva Pharmaceuticals USA

Class I - Dangerous

Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.

Aug 6, 2018 Prescription Drugs View Details →

Metformin 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

Teva Pharmaceuticals USA

Class I - Dangerous

Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.

Aug 6, 2018 Prescription Drugs View Details →

Bumetanide Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0542-11

Upsher Smith Laboratories

Class I - Dangerous

Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.

Sep 19, 2018 Prescription Drugs Nationwide View Details →

PIO&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

Teva Pharmaceuticals USA

Class I - Dangerous

Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.

Aug 6, 2018 Prescription Drugs View Details →

Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only, 31818 US Hwy 19N, Palm Harbor, FL 34684

Promise Pharmacy

Class I - Dangerous

Presence of precipitate

Oct 18, 2018 Prescription Drugs Nationwide View Details →

Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0541-11

Upsher Smith Laboratories

Class I - Dangerous

Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.

Sep 19, 2018 Prescription Drugs Nationwide View Details →