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  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

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

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 2601–2620 of 17,723 recalls

Class IOngoing

Purely Soothing 15% MSM Drops, packaged in a)15 ml, .5 fl oz bottle, UPC 7 31034 91382 9; and b) 30 ml, 1.014 fl oz bottle, UPC 7 31034 91379 9; Manufactured by: Pharmedica USA, Phoenix, AZ.

Pharmedica USA, LLC

Non-Sterility

February 14, 2023 · DrugView details →
Class IIOngoing

Purely Soothing MSM Nasal Spray, 15%, packaged in 30ml, 1.014 fl. oz bottles, Manufactured by: Pharmedica USA, Phoenix, AZ, UPC 7 31034 91380 5

Pharmedica USA, LLC

CGMP Deviations

February 14, 2023 · DrugView details →
Class ITerminated

PrimeZEN Black 6000 capsule, 2000mg, Male Sexual Performance Enhancement, 1-count blister card, Distributed by: Prime Premier Group, Los Angeles, CA 90006, UPC 7 28175 52189 1.

Volt Candy Wholesale Club

Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

February 13, 2023 · DrugView details →
Class IICompleted

0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-10

B. Braun Medical Inc.

Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of the product.

February 10, 2023 · DrugView details →
Class IICompleted

0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00

B. Braun Medical Inc.

Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of the product.

February 10, 2023 · DrugView details →
Class IITerminated

allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count cartons (NDC 11673-617-22), b)30-count cartons (NDC 11673-617-39), c)70-count cartons (NDC 11673-617-01), and d)150-count cartons (11673-617-47), Distributed by: Target Corporation, Minneapolis, MN 55403.

L. Perrigo Company

Failed Impurities/Degradation Specifications

February 9, 2023 · DrugView details →
Class IITerminated

Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 36800-691-39), b)45-count cartons (NDC 36800-691-95), and 90-count cartons (NDC 36800-691-75), Distributed by: Topco Associates LLC, Elk Grove Village, IL 60007.

L. Perrigo Company

Failed Impurities/Degradation Specifications

February 9, 2023 · DrugView details →
Class IITerminated

allergyrelief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)30-count cartons (NDC 56062-847-39); and b) 45-count cartons (NDC 56062-847-95), Distributed by: Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811.

L. Perrigo Company

Failed Impurities/Degradation Specifications

February 9, 2023 · DrugView details →
Class IITerminated

Maximum Zone2 Topical Analgesic, 1oz bottle, for use during a pain sensitive procedure, distributed by: DERMAL SOURCE, Portland, OR, www.dermalsource.com, 1-866-568-3223, NDC code: 80069-012-01, Drug Facts- For use by licensed professionals only' Active Ingredients- Lidocaine HCL (5%), Epinephrine (0.01%).

HTO Nevada, Inc.

cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.

February 9, 2023 · DrugView details →
Class IITerminated

allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count cartons (NDC 79481-0847-0), b)30-count cartons (NDC 79481-0847-1), and c) 45-count cartons (NDC 79481-0847-2), Distributed by: MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544.

L. Perrigo Company

Failed Impurities/Degradation Specifications

February 9, 2023 · DrugView details →
Class IITerminated

Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 30-count cartons, Distributed By: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. NDC 69842-0914-39

L. Perrigo Company

Failed Impurities/Degradation Specifications

February 9, 2023 · DrugView details →
Class IITerminated

Fexofenadine Hydrochloride Tablets, 180 mg, 100-count cartons, Distributed by: Perrigo, Allegan, MI 49010. NDC 45802-847-78

L. Perrigo Company

Failed Impurities/Degradation Specifications

February 9, 2023 · DrugView details →
Class IITerminated

Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 15-count cartons, Distributed By: Adusa Distribution, LLC, Salisbury, NC 28147. NDC 72476-847-22

L. Perrigo Company

Failed Impurities/Degradation Specifications

February 9, 2023 · DrugView details →
Class IITerminated

New & Improved Blue Gel Anesthetic, to reduce pain and swelling during pain sensitive procedures, 1 oz bottle, distributed by Dermal Source, Portland, OR, www.dermalsource.com 1-888-568-3223. NDC Code: 80069-008-01. Drug Facts- For use by licensed professionals only, Active Ingredients -Lidocaine HCL (5%), Tetracaine HCL (1%) and epinephrine (0.1%).

HTO Nevada, Inc.

cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.

February 9, 2023 · DrugView details →
Class IITerminated

Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 0113-0847-39), and b) 45-count cartons (NDC 0113-0847-95), Distributed by: Perrigo, Allegan, MI 49010.

L. Perrigo Company

Failed Impurities/Degradation Specifications

February 9, 2023 · DrugView details →
Class IITerminated

Picnic, Fexofenadine Hydrochloride Tablets, 180 mg, Antihistamine, 90-count cartons, Distributed by: Thirty Madison, Inc., New York, NY 10001. NDC 45 tablets: 80159-112-03

L. Perrigo Company

Failed Impurities/Degradation Specifications

February 9, 2023 · DrugView details →
Class IITerminated

Allergy, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 72288-847-39), and b)150-count cartons (NDC 72288-847-47 and 72288-847-37), Distributed By: Amazon.com Services LLC., 410 Terry Avenue N., Seattle, WA 98109.

L. Perrigo Company

Failed Impurities/Degradation Specifications

February 9, 2023 · DrugView details →
Class IITerminated

Non-Drowsy Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 150-count cartons, Distributed By: BJ's Wholesale Club, 25 Research Drive, Westborough, MA 01581. NDC 68391-847-47

L. Perrigo Company

Failed Impurities/Degradation Specifications

February 9, 2023 · DrugView details →
Class IITerminated

Allergy ALLER-FEX, Fexofenadine Hydrochloride Tablets, 180 mg, 180-count cartons, Packaged by: Perrigo, 515 Eastern Ave., Allegan, MI 49010 USA. NDC 63981-847-48

L. Perrigo Company

Failed Impurities/Degradation Specifications

February 9, 2023 · DrugView details →
Class IITerminated

aller-ease, Fexofenadine Hydrochloride Tablets, 180 mg, 30-count cartons, Packaged For: Your Military Exchanges, By: Perrigo Company, Allegan, MI USA 49010. NDC 55301-847-39

L. Perrigo Company

Failed Impurities/Degradation Specifications

February 9, 2023 · DrugView details →
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