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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 4281–4300 of 17,755 recalls

Class IITerminated

Secret, Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Light Essentials, Topical spray can Net Wt 3.8 oz (107 g), Dist. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-382-10, UPC 0 37000 72992 1

The Procter & Gamble Company

CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene

November 23, 2021 · DrugView details →

Class IITerminated

Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, 100-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Manufactured by: Ascent Pharmaceuticals, Inc., Central Islip, NY 11722, NDC 31722-997-01.

Ascent Pharmaceuticals, Inc.

Product Mix-up

November 19, 2021 · DrugView details →

Class ICompleted

AmericanScreening HAND SANITIZER (ethyl alcohol 70%) ANTIMICROBIAL FORMULA Vitamin E & Moisturizer, 8 FL OZ (237 mL) bottle with either a black or clear top, Distributed by American Screening LLC Shreveport, LA, 71106 UPC 8 40050 51579 2

American Screening LLC

Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.

November 19, 2021 · DrugView details →

Class IIITerminated

Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets, 0.451 mg), packaged in cartons containing 3 wallets of 28 Tablets each, Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United Stated, Manufactured by: Lupin Limited, Pithampur, (M.P.) - 454775, India, 244896, The individual wallet NDC 68180-904-11 and the carton NDC 68180-904-13.

Lupin Pharmaceuticals Inc.

Subpotent Drug

November 19, 2021 · DrugView details →

Class IITerminated

Ascorbic Acid Solution for Injection, 500 mg/mL, 50 mL Multiple Dose Vial, For IM, IV or SC Use Only, Rx only, ASP Cares, 2414 Babcock Rd Ste #106, San Antonio, TX 78229 NDC 72833-690-50

ASP CARES

Lack of Assurance of Sterility

November 17, 2021 · DrugView details →

Class IITerminated

Methylcobalamin Solution for Injection, 1 mg/mL, 30 mL Multiple Dose Vial, For IM, SC or IV Use Only, Rx only, ASP Cares2414 Babcock Rd Ste #106, San Antonio, TX 78229 NDC 72833-565-30

ASP CARES

Lack of Assurance of Sterility

November 17, 2021 · DrugView details →

Class ITerminated

Odor-Eaters Spray Powder, Tolnaftate 1% Antifungal, packaged in a) 4 oz. aerosol cans (UPC 0 41388 0041 2, NDC 10157-4645-1) and b) 5.3 oz. aerosol cans (UPC 0 41388 00411 2, NDC 10157-4645-2) Blistex P.O. Box 5392, Oak Brook, IL 60522-5392.

Blistex Inc

Chemical contamination: Presence of benzene

November 17, 2021 · DrugView details →

Class ICompleted

Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Rx Only; 0.4 mL Syringes, Manufactured for Sandoz Inc., Princeton, NJ 08540, NDC 00781-3246-02; Carton (10 x 0.4 mL Syringes), Manufactured by Shenzhen Techdow Pharmaceutical Co., Ltd. Shenzhen City, Guangdong Province 518057, China for Sandoz Inc., Princeton, NJ 08540, NDC 00781-3246-64

Sandoz Inc

Temperature Abuse; temperature excursion during shipping

November 17, 2021 · DrugView details →

Class IITerminated

Biotin Solution for Injection, 10 mg/mL, 30 mL Multiple Dose Vial, Sterile, For IM or IV use only, Rx only ASP Cares, 2414 Babcock Rd Ste #106, San Antonio, TX 78229 NDC 72833-0589-30

ASP CARES

Lack of Assurance of Sterility

November 17, 2021 · DrugView details →

Class IIITerminated

Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by: Aurobindo Pharma USA Inc., 279 Princeton-Hightstown Road, East Windsor, NJ, 08520, Made in India, NDC 65862-143-05

Aurobindo Pharma USA Inc.

Failed Impurities/Degradation Specifications

November 15, 2021 · DrugView details →

Class IITerminated

MORPHINE SULFATE, in 0.9% Sodium Chloride Injection, 50 mg per 50 mL, (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-427-01.

SterRx, LLC

Lack of Assurance of Sterility

November 12, 2021 · DrugView details →

Class IITerminated

NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-002-01.

SterRx, LLC

Lack of Assurance of Sterility

November 12, 2021 · DrugView details →

Class IIITerminated

12 HR Allergy & Congestion Relief Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg Antihistamine I Nasal Decongestant, 20 Extended-Release Tablets USP, Distributed By Cardinal Health, Dublin, Ohio 43107, Made in India, NDC 70000-0518-1.

Dr. Reddy's Laboratories, Inc.

Failed dissolution specifications

November 12, 2021 · DrugView details →

Class IITerminated

NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 0.9% Sodium Chloride Injection, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-926-01.

SterRx, LLC

Lack of Assurance of Sterility

November 12, 2021 · DrugView details →

Class IITerminated

NOREPINEPHRINE, 8 mg per 250 mL, (32 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-676-01.

SterRx, LLC

Lack of Assurance of Sterility

November 12, 2021 · DrugView details →

Class IIITerminated

Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy & Congestion, 12 Hour, 30 Tablets, Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152, www.rugbylaboratories.com. NDC 0638-1242-07.

Dr. Reddy's Laboratories, Inc.

Failed dissolution specifications

November 12, 2021 · DrugView details →

Class IIITerminated

Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy & Congestion, 12 Hour, 20 Tablets, Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152, www.rugbylaboratories.com. NDC 0536-1242-34.

Dr. Reddy's Laboratories, Inc.

Failed dissolution specifications

November 12, 2021 · DrugView details →

Class IITerminated

Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 1 mg per 100 mL, (10 mcg per mL), Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-327-01.

SterRx, LLC

Lack of Assurance of Sterility

November 12, 2021 · DrugView details →

Class IITerminated

PHENYLephrine HCl, 40 mg per 250 mL, (160 mcg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-252-01.

SterRx, LLC

Lack of Assurance of Sterility

November 12, 2021 · DrugView details →

Class IITerminated

Succinylcholine Chloride Injection, 200 mg per 10 mL (20 mg per mL), 1,000 mL, Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-826-01.

SterRx, LLC

Lack of Assurance of Sterility

November 12, 2021 · DrugView details →

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