US Drug Recall Register

FDA Drug Recalls

11,815 recalls · Class II, newest first

Class II · Moderate risk Terminated

Bacteriostatic water for injection packaged in an amber glass injectable vial

Reason Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Martin Avenue Pharmacy, Inc. D-0062-2015
Class II · Moderate risk Terminated

Atropine sulfate 2 mg/mL injectable packaged in an amber glass injectable vial

Reason Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Martin Avenue Pharmacy, Inc. D-0061-2015
Class II · Moderate risk Terminated

Atropine sulfate 1 mg/mL injectable packaged in an amber glass injectable vial

Reason Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Martin Avenue Pharmacy, Inc. D-0060-2015
Class II · Moderate risk Terminated

Atropine sulfate 0.5% opthalmic solution packaged in a squeeze…

Reason Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Martin Avenue Pharmacy, Inc. D-0059-2015
Class II · Moderate risk Terminated

Atropine sulfate 0.01% opthalmic solution packaged in a squeeze…

Reason Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Martin Avenue Pharmacy, Inc. D-0058-2015
Class II · Moderate risk Terminated

Alprostadil alcohol 500 mcg/mL injectable packaged in amber glass…

Reason Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Martin Avenue Pharmacy, Inc. D-0057-2015
Class II · Moderate risk Terminated

Acetylcysteine 10% opthalmic solution packaged in an opaque…

Reason Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Martin Avenue Pharmacy, Inc. D-0056-2015
Class II · Moderate risk Terminated

Acetylcysteine 20%

Reason Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Martin Avenue Pharmacy, Inc. D-0055-2015
Class II · Moderate risk Terminated

Acetylcysteine 10%

Reason Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Martin Avenue Pharmacy, Inc. D-0054-2015
Class II · Moderate risk Terminated

Propranolol Hydrochloride Injection

Reason CGMP Deviations: Citations given to API supplier by the Italian Health Agency AIFA for several critical deficiencies which caused a recall of the API lot used to manufacture Propanolo HCl Injection.

Fresenius Kabi USA, LLC NDC 63323-604-01 D-1545-2014
Class II · Moderate risk Terminated

Metoclopramide Oral Solution

Reason Defective Container: Product leaks when inverted.

VistaPharm, Inc. NDC 66689-031-01 D-0010-2015
Class II · Moderate risk Terminated

Rector's Remedy OINTMENT

Reason Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing and lack of OTC drug labeling requirements.

New Gpc Inc. D0035-2015
Class II · Moderate risk Terminated

Whitfield's OINTMENT B.P.

Reason Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A.

New Gpc Inc. D0034-2015
Class II · Moderate risk Terminated

Whitfield Lotion

Reason Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A..

New Gpc Inc. D0033-2015
Class II · Moderate risk Terminated

Ferrol EXPECTORANT

Reason Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A..

New Gpc Inc. D0032-2015
Class II · Moderate risk Terminated

Mustarcreme

Reason Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A..

New Gpc Inc. D0031-2015
Class II · Moderate risk Terminated

alcosulph Astringent Lotion

Reason Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A..

New Gpc Inc. D0030-2015
Class II · Moderate risk Terminated

alcosulph Moisturizing Cream

Reason Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A..

New Gpc Inc. D0029-2015
Class II · Moderate risk Terminated

Alcohol-Free Hand Sanitizer

Reason Microbial Contamination of Non-Sterile Product

HLI dba Humphreyline Inc D-1518-2014
Class II · Moderate risk Terminated

Children's Q-Pap

Reason Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint.

Qualitest Pharmaceuticals NDC 0603-0843-54 D-0039-2015
Class II · Moderate risk Terminated

Children's Q-Pap

Reason Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint.

Qualitest Pharmaceuticals NDC 0603-0842-54 D-0038-2015
Class II · Moderate risk Terminated

Children's Q-Pap

Reason Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint.

Qualitest Pharmaceuticals NDC 0603-0841-54 D-0037-2015
Class II · Moderate risk Terminated

ZyGenerics ATENOLOL Tablets

Reason Superpotent Drug: A complaint was reported by a pharmacist who stated several tablets were noticeably thicker in appearance.

Zydus Pharmaceuticals USA Inc NDC 68382-022-01 D-0007-2015