🍔 Food 💊 Drugs 🏥 Medical Devices
MVASI (bevacizumab-awwb), Injection, For Intravenous Infusion After Dilution, 100 mg/4 ml, Single dose vial, Rx only, Manufactured by Amgen Inc. Thousand Oaks, CA 91320-1799, NDC 55513-0206-01 Class II

Reason: Defective container: loose crimp defect, potential loss of container integrity.

Amgen, Inc. 20220502 Terminated
Distributed: Nationwide in the USA, Egypt and Lithuania.
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Xanax XR (alprazolam) extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Fizer Inc, NY, NY 10017, NDC 0009-0068-07. Class II

Reason: Failed Dissolution Specifications: low out of specification results for dissolution.

Viatris Inc 20220428 Terminated
Distributed: Product was distributed nationwide in the USA
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The Mandalorian Hand Sanitizer, ethyl alcohol 68%, 2.11 oz./60 mL bottles, Best Brands Consumer Products, Inc., c/o Best Brands Sales Company LLC, New York, NY NDC 74530-012-02 Class I

Reason: Chemical Contamination; FDA analysis found product to contain benzene

Best Brands Consumer Products, Inc. 20220329 Terminated
Distributed: Nationwide in the US
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Mickey Mouse Hand Sanitizer, ethyl alcohol 68%, 2.11 oz./to mL bottle, Best Brands Consumer Products, Inc., c/o Best Brands Sales Company LLC, New York, NY NDC 74530-013-02 Class I

Reason: Chemical Contamination; FDA analysis found product to contain methanol

Best Brands Consumer Products, Inc. 20220329 Terminated
Distributed: Nationwide in the US
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Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 10 Packs of 10 Tablets each, 100 Tablets per blister pack, Rx Only, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540, Made in India, NDC 43598-561-78. Class II

Reason: Failed Dissolution Specifications

Dr. Reddy's Laboratories, Inc. 20220415 Terminated
Distributed: OH
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Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg, Rx Only, 90 tablets per bottle, Manufactured by: Torrent Pharmaceuticals Ltd., Indrad-382 721, India, Manufactured for: Torrent Pharma Inc., Levittown, PA 19057, NDC# 13668-096-90. Class II

Reason: CGMP deviations: tablets cracking

Torrent Pharma Inc 20220411 Terminated
Distributed: Nationwide in the U.S.A
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Erythromycin Topical Gel USP, 2%, Net Wt 60 g tube, Rx only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310 Distributed by: McKesson Corporation dba Sky Packaging 4971 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-053-68 Class II

Reason: CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.

McKesson Corporation dba McKesson Drug Company 20220421 Ongoing
Distributed: Nationwide in the United States including Guam and the Northern Mariana Islands.
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Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented) (Potency expressed as betamethasone), 15 gram tube, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-996-65 Class II

Reason: CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.

McKesson Corporation dba McKesson Drug Company 20220421 Ongoing
Distributed: Nationwide in the United States including Guam and the Northern Mariana Islands.
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Lidocaine Prilocaine Cream USP, 2.5%/2.5% Net Wt. 30 gram tube, Rx Only, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southridge Blvd., Suite 101 Memphis, TN 38141 Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, NDC 63739-054-66 Class II

Reason: CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.

McKesson Corporation dba McKesson Drug Company 20220421 Ongoing
Distributed: Nationwide in the United States including Guam and the Northern Mariana Islands.
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Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL bottle, Rx only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310 Distributed by: McKesson Corporation dba Sky Packaging 4071 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-977-64 Class II

Reason: CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.

McKesson Corporation dba McKesson Drug Company 20220421 Ongoing
Distributed: Nationwide in the United States including Guam and the Northern Mariana Islands.
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