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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 4581–4600 of 17,755 recalls

Class ITerminated

Coppertone SPORT MINERAL 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02870 1

Beiersdorf Inc

Chemical contamination; presence of benzene

September 30, 2021 · DrugView details →

Class IITerminated

Coppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02880 0

Beiersdorf Inc

cGMP Deviations

September 30, 2021 · DrugView details →

Class ITerminated

Coppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02882 4

Beiersdorf Inc

Chemical contamination; presence of benzene

September 30, 2021 · DrugView details →

Class ITerminated

Coppertone SPORT Sunscreen Spray 50, (To Deliver) Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 5%, NET WT 1.6 OZ (45 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 41100 00506 9

Beiersdorf Inc

Chemical contamination; presence of benzene

September 30, 2021 · DrugView details →

Class ITerminated

Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02881 7

Beiersdorf Inc

Chemical contamination; presence of benzene

September 30, 2021 · DrugView details →

Class IITerminated

Coppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02882 4

Beiersdorf Inc

cGMP Deviations

September 30, 2021 · DrugView details →

Class IITerminated

Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02881 7

Beiersdorf Inc

cGMP Deviations

September 30, 2021 · DrugView details →

Class ITerminated

Coppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02880 0

Beiersdorf Inc

Chemical contamination; presence of benzene

September 30, 2021 · DrugView details →

Class IIIOngoing

Butalbital, APAP, Caf 50/325/40 Tablet, packaged in a) 12-count bottles, NDC: 71335-1767-09, barcode 083929164865; b) 20-count bottles, NDC: 71335-1767-01, barcode 083921157837; c) 30-count bottles, NDC: 71335-1767-02, barcode 083922165687, d) 60-count bottles, NDC: 71335-1767-03, barcode 083923153776, e) 90-count bottles, NDC: 71335-1767-04, barcode 083924152889, f) 120-count bottles, NDC: 71335-1767-07, barcode 083927153735. Westminster Pharmaceuticals LLC, Rx only, Packaged by Bryant Ranch Prepack, Burbank, CA 91504 USA

Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals

Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label

September 28, 2021 · DrugView details →

Class IIOngoing

The Natural Dentist Healthy Balance Peppermint Sage, Menthol 0.12%, 16.9 FL OZ (500 mL) bottles, Manufactured for Revive Personal Products Company, Madison, NJ 07940, UPC 7 14132 00071 4

Revive Personal Products Company

Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Menthol with UPC 7 14132 00071 4 instead of Peppermint Oil and Sage Oil with UPC 7 14132 00073 8

September 28, 2021 · DrugView details →

Class IIIOngoing

Butalbital, APAP, Caf 50/325/40 Tablets, packaged in a) 12-count bottles, NDC: 63629-8392-09, barcode 083929152151; b) 60-count bottles, NDC: 63629-8392-03, barcode 083923152614; c) 90-count bottles, NDC:63629-8392-04, barcode 083924152614, Lannett Company Inc; Rx only, Packaged by Bryant Ranch Prepack, Burbank, CA 91504.

Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals

Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label

September 28, 2021 · DrugView details →

Class IITerminated

Artesunate for Injection, 110 mg/vial, packaged in a) 2x2 pack containing 2 Single-dose vials artesunate (73607-001-01) and 2 vials sterile diluent (NDC 73607-001-02) per carton (NDC 73607-001-11); 4x4 pack containing 4 Single-dose vials artesunate (73607-001-01) and 4 vials sterile diluent (NDC 73607-001-02) per carton (NDC 73607-001-10), Rx only, Mfg for: Amivas, LLC, 1209 Orange St., Wilmington, Delaware 19801.

AMIVAS (US), LLC

Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance.

September 27, 2021 · DrugView details →

Class IITerminated

Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500 Tablets, Rx Only, Manufactured by: Strides Shasun Limited, Bengaluru - 562106, India, Distributed by: Strides Pharma In., East Brunswick, NJ 08816, NDC 64380-861-07.

Strides Pharma Inc.

Failed Dissolution Specifications

September 27, 2021 · DrugView details →

Class ITerminated

Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial; Diluent for Glucagon, 1 mL syringe. Rx only, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285; Glucagon, NDC: 0002-8031-01

Eli Lilly & Company

SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of full drug effect upon administration.

September 24, 2021 · DrugView details →

Class IITerminated

Hydroquinone USP, 4% Skin Bleaching Cream, Rx only, Net Wt 1 oz (28.35g), Manufactured for: Westminster Pharmaceuticals, LLC Nashville, TN 37217 NDC 69367-174-01

Monarch PCM, LLC

Finished product specification did not meet USP specifications.

September 23, 2021 · DrugView details →

Class IITerminated

Testosterone Cypionate Testosterone Propionate, 180mg/mL, 20mg/mL, 1 mL vial, Rx only, New Vitalis Pharmacy 4139 Cadillac Ct # 201 Louisville, KY 40213

New Vitalis Pharmacy LLC dba New Vitalis Pharmacy

Lack of Assurance of Sterility

September 22, 2021 · DrugView details →

Class IITerminated

AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC Frazer, PA 19355, Manufactured in Ireland, NDC 59310-111-06

Teva Pharmaceuticals USA

Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol

September 22, 2021 · DrugView details →

Class IITerminated

AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, Rx Only, Mktd by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-530-08.

Teva Pharmaceuticals USA

Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol

September 22, 2021 · DrugView details →

Class IITerminated

AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd. by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-129-06.

Teva Pharmaceuticals USA

Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol

September 22, 2021 · DrugView details →

Class IITerminated

Potassium Chloride 40 mEq in 0.9% Sodium Chloride 270 mL NS, 250 mL bag, Rx Only, SSM Health Care Corporation, 1015 Bowles, Fenton, MO. NDC 60652-6429-1

SSM Health Care St. Louis DBA SSM St. Clare Health Center

Lack of Assurance of Sterility

September 22, 2021 · DrugView details →

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