Drug Recall
Terminated
Historical recordClass II
Cefazolin forte 50 mg/mL opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
by Martin Avenue Pharmacy, Inc.
- 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.
- Recall initiated
- August 27, 2014
- Reported by FDA
- November 5, 2014
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Cefazolin forte 25 mg/mL opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
by Martin Avenue Pharmacy, Inc.
- 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.
- Recall initiated
- August 27, 2014
- Reported by FDA
- November 5, 2014
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Calcium chloride (PF) 100 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
by Martin Avenue Pharmacy, Inc.
- 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.
- Recall initiated
- August 27, 2014
- Reported by FDA
- November 5, 2014
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Bupivacaine hydrochloride 0.25% injectable packaged in an amber glass injectable vial,Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
by Martin Avenue Pharmacy, Inc.
- 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.
- Recall initiated
- August 27, 2014
- Reported by FDA
- November 5, 2014
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Benzalkonium chloride water for injection packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
by Martin Avenue Pharmacy, Inc.
- 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.
- Recall initiated
- August 27, 2014
- Reported by FDA
- November 5, 2014
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Bacteriostatic water for injection packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
by Martin Avenue Pharmacy, Inc.
- 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.
- Recall initiated
- August 27, 2014
- Reported by FDA
- November 5, 2014
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Atropine sulfate 2 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
by Martin Avenue Pharmacy, Inc.
- 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.
- Recall initiated
- August 27, 2014
- Reported by FDA
- November 5, 2014
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Atropine sulfate 1 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
by Martin Avenue Pharmacy, Inc.
- 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.
- Recall initiated
- August 27, 2014
- Reported by FDA
- November 5, 2014
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Atropine sulfate 0.5% opthalmic solution packaged in a squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
by Martin Avenue Pharmacy, Inc.
- 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.
- Recall initiated
- August 27, 2014
- Reported by FDA
- November 5, 2014
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Atropine sulfate 0.01% opthalmic solution packaged in a squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
by Martin Avenue Pharmacy, Inc.
- 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.
- Recall initiated
- August 27, 2014
- Reported by FDA
- November 5, 2014
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Alprostadil alcohol 500 mcg/mL injectable packaged in amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
by Martin Avenue Pharmacy, Inc.
- 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.
- Recall initiated
- August 27, 2014
- Reported by FDA
- November 5, 2014
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Acetylcysteine 10% opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
by Martin Avenue Pharmacy, Inc.
- 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.
- Recall initiated
- August 27, 2014
- Reported by FDA
- November 5, 2014
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Acetylcysteine 20% (PF) inhalant solution packaged in either a 3 mL or 7 mL vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
by Martin Avenue Pharmacy, Inc.
- 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.
- Recall initiated
- August 27, 2014
- Reported by FDA
- November 5, 2014
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Acetylcysteine 10% (PF) inhalant solution packaged in either a 3 mL or 7 mL vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
by Martin Avenue Pharmacy, Inc.
- 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.
- Recall initiated
- August 27, 2014
- Reported by FDA
- November 5, 2014
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass III
APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 522 mg, a) 7-count HDPE bottle (NDC 0024-5812-07), b) 30-count HDPE bottle (NDC 0024-5812-30), Rx Only, Manufactured by Valeant Pharmaceuticals International, Inc. Steinbach MB, Canada R5G 1Z7
by Valeant Pharmaceuticals North America LLC
- Reason
- Labeling: Incorrect or Missing Package Insert
- Recall initiated
- June 5, 2014
- Reported by FDA
- November 5, 2014
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass III
APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 348 mg, a) 7-count HDPE bottle (NDC 0024-5811-07), b) 30-count HDPE bottle (NDC 0024-5811-30), Rx Only, Manufactured by Valeant Pharmaceuticals International, Inc. Steinbach MB, Canada R5G 1Z7
by Valeant Pharmaceuticals North America LLC
- Reason
- Labeling: Incorrect or Missing Package Insert
- Recall initiated
- June 5, 2014
- Reported by FDA
- November 5, 2014
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass III
APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 174 mg, 7-count HDPE bottle, Rx Only, Manufactured by Valeant Pharmaceuticals International, Inc. Steinbach MB, Canada R5G 1Z7, NDC 0024-5810-07.
by Valeant Pharmaceuticals North America LLC
- Reason
- Labeling: Incorrect or Missing Package Insert
- Recall initiated
- June 5, 2014
- Reported by FDA
- November 5, 2014
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets, (CII), 10 mg, 100 Tablet Bottles, Rx Only. Teva Pharmaceuticals USA , Sellersville, PA 18960, NDC: 0555-0972-02. 0555-0972-02, lot #s 34016373A, 34016377A, exp. dated 7/2016.
by Teva Pharmaceuticals USA
- Reason
- Failed Impurities/Degradation Specifications: Out of specification for unknown impurities.
- Recall initiated
- October 8, 2014
- Reported by FDA
- November 5, 2014
- Distribution
- U.S. Nationwide including Puerto Rico.
View recall →
Drug Recall
Terminated
Historical recordClass III
Carbamazepine Tablets USP, 200 mg, 1000 Tablets per Bottle, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 26110 Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4005-3.
by Taro Pharmaceuticals U.S.A., Inc.
- Reason
- Marketed without an Approved NDA/ANDA: One lot was on hold-pending release status when it was erroneously made available for sale in the inventory control system. An alternate manufacturing site for the Carbamazepine API final intermediate was pending approval.
- Recall initiated
- October 21, 2014
- Reported by FDA
- November 5, 2014
- Distribution
- IL, OH, LA
View recall →
Drug Recall
Terminated
Historical recordClass II
HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL, Net Wt 16 fl oz (473 mL), NDC 50383-796-16, Rx Only, Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701, ALSO LABELED AS HydrOXYzine HCl Oral Solution, USP, 10 mg / 5 mL, Net Wt 16 fl oz (473 mL), NDC 10702-052-16, Rx Only, Manufactured for: KVK-TECH, INC. NEWTOWN, PA 18940, MADE IN USA, Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701.
by Hi-Tech Pharmacal Co., Inc.
- Reason
- Failed Impurity/Degradation Specification; out-of-specification result for one individual unknown impurity at the 24-month room temperature stability test station.
- Recall initiated
- April 1, 2014
- Reported by FDA
- November 5, 2014
- Distribution
- nationwide
View recall →
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace
does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice --
always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take.
Read the full medical disclaimer.
