Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with Sildenafil an ingredient found in an FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.

Oct 16, 2023 Prescription Drugs View Details →

Liothyronine Sodium Tablets, USP 5 mcg, 100-count bottle, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India. NDC 62756-589-88

SUN PHARMACEUTICAL INDUSTRIES

Class I - Dangerous

Failed Impurities/Degradation Specifications

Dec 4, 2023 Prescription Drugs Nationwide View Details →

Votrient (pazopanib) 200 mg tablets, 120-count bottle, Rx Only, Manufactured by: Siegried Barbera, S.L., Barbera del Valles, Spain, Distributed by: Novartis Pharmaceuticals Corp., East Hanover, N.J. 07936, NDC 0078-1077-66

Siegfried Barbera, SL

Class I - Dangerous

Failed Dissolution Specifications

Nov 20, 2023 Prescription Drugs Nationwide View Details →

Penicillamine Tablets USP 250 mg, 100-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 Manufactured by: Lupin Limited, Nagpur-441 108, India, NDC# 70748-153-01

Lupin Pharmaceuticals

Class I - Dangerous

Failed Dissolution Specifications

Nov 22, 2023 Prescription Drugs View Details →

Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, Rx Only, Manufactured By: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharmacity, Selaqui Industrial Area, Dehradun-248 197 Uttarakhand, India Distributed By: Padagis, Allegan, MI 49010. NDC: 0574-0118-30

Padagis US

Class I - Dangerous

Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules

Nov 1, 2023 Prescription Drugs Nationwide View Details →

Dr. Ergin's SugarMD, ADVANCED GLUCOSE SUPPORT Capsules, Dietary Supplement, helps support healthy glucose levels a) 60 count (UPC 1 95893 92767 8), b) 120 count (UPC 1 95893 54697 8), c) 180 count (UPC 1 95893 99957 6) bottles, Manufactured for SUGARMDS LLC, Port St. Lucie, FL 34952.

SUGARMDS

Class I - Dangerous

MARKETED WITHOUT AN APPROVED NDA/ANDA: Product found to be tainted with metformin and glyburide

Nov 8, 2023 Prescription Drugs Nationwide View Details →

buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 47335-738-86

SUN PHARMACEUTICAL INDUSTRIES

Class I - Dangerous

Failed Dissolution Specifications

Nov 22, 2023 Prescription Drugs Nationwide View Details →

LET Gel (Lidocaine HCL/Epinephrine Bitartrate/Tetracaine HCL 4%/0.18%/0.5% Topical Gel), Single-use Topical Syringe, 3mL syringe, 10/pack, Rx only, Carie Boyd Pharmaceuticals, 8400 Esters Blvd, Ste# 190, Irving, TX 75063, NDC73271-1003-1

Right Value Drug Stores, LLC

Class I - Dangerous

Product Mix-up: Incorrect Product Formulation

Nov 9, 2023 Prescription Drugs Nationwide View Details →

ceFAZolin sodium in Sterile Water for injection, Injectable Solution, 1g/10mL (0.1 g per mL), Syringe, Rx only, Wells Pharma, NDC 73702-131-10

Wells Pharma of Houston

Class I - Dangerous

Lack of assurance of sterility.

Nov 22, 2023 Prescription Drugs View Details →

KinderMed INFANTS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor, 2 FL OZ (59 mL), Distributed By: KinderFarms, Redondo Beach, CA 90277, NDC 82673-096-02, UPC 850001805698.

KINDER FARMS

Class I - Dangerous

Failed Impurities/Degradation Specifications

Nov 13, 2023 Prescription Drugs Nationwide View Details →

ROPivacaine HCl 0.2% PF in Sodium Chloride 1,000 mg/500 mL (2 mg per mL) Injection, 500 mL bags, Rx only, STAQ Pharma Inc. 14135 E 42nd Ave, Unit 50, Denver, Colorado 80239, NDC 73177-0109-26,

STAQ Pharma

Class I - Dangerous

STAQ Pharma Inc. received consumer complaints related to leaking bags and other potential bag concerns. Upon investigation, they determine the source of the issue was with the bag manufacturer who released bags Lot # 134142-001A which had failed internal QC tests for leaks.

Nov 29, 2023 Prescription Drugs Nationwide View Details →

Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Manufactured by: Baxter Pharmaceuticals India Private Ltd, Ahmedabad 382213, India. NDC 36000-012-25

Baxter Healthcare

Class I - Dangerous

Failed pH Specifications

Nov 14, 2023 Prescription Drugs Nationwide View Details →

SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Huningue, France, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936. NDC 0078-0110-22

Novartis Pharmaceuticals

Class I - Dangerous

Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals

Nov 22, 2023 Prescription Drugs Nationwide View Details →

KinderMed KIDS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor, 4 FL OZ (118 mL), Distributed By: KinderFarms, Redondo Beach, CA 90277, NDC 82673-097-04, UPC 850001805728.

KINDER FARMS

Class I - Dangerous

Failed Impurities/Degradation Specifications

Nov 13, 2023 Prescription Drugs Nationwide View Details →

Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 60505-0084-1, b)100-count bottle, NDC#:60505-0084-2, c)1000-count bottle, NDC#: 60505-0084-4, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.

Apotex

Class I - Dangerous

Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine

Nov 1, 2023 Prescription Drugs Nationwide View Details →

PAROXETINE tablets, USP, 10 mg, Packaged as a) 30-count bottle, NDC 60429-734-30; b) 90-count bottle NDC 60429-734-90; c)1000-count bottle, NDC 60429-734-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M9L 1T9, Packaged by GSMS, Incorporated, Camarillo, CA 93012.

Golden State Medical Supply

Class I - Dangerous

Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine

Nov 10, 2023 Prescription Drugs Nationwide View Details →

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