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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 741–760 of 1,000 recalls

Class IITerminated

Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-11

Denver Solutions, LLC DBA Leiters Health

CGMP DEVIATIONS

February 21, 2023 · DrugView details →

Class IITerminated

Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-15

Denver Solutions, LLC DBA Leiters Health

CGMP DEVIATIONS

February 21, 2023 · DrugView details →

Class II

Terminated

Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-148-94

Denver Solutions, LLC DBA Leiters Health

CGMP DEVIATIONS

February 21, 2023 · DrugView details →

Class IITerminated

Warfarin Sodium Tablets, USP 1 mg, 100-count bottle, Rx Only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC# 57237-119-01

RISING PHARMACEUTICALS

Failed Impurities/Degradation Specifications

February 15, 2023 · DrugView details →

Class IITerminated

Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL multiple-dose vials (NDC 52536-625-10) and b) 1 mL single dose vials (NDC 52536-625-01), Rx only, Mfd for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328.

Azurity Pharmaceuticals, Inc.

cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.

February 15, 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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