Class I - Dangerous
CGMP Deviations: Pharmaceutical for injection was not manufactured according to Good Manufacturing Procedures.
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Prescription Drugs
💊 Drugs • 12,141 recalls
Class I - Dangerous
Presence of Foreign Tablets/Capsules: Recall is being conducted due to a foreign capsule found in one bottle.
Class I - Dangerous
Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug.
Class I - Dangerous
Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug.
Class I - Dangerous
Lack of Assurance of Sterility: There is the potential for the solution to leak from the seal of the fill tube to the bag.
ABILIFY (aripiprazole) Tablets, 30 mg, Rx only, Blister Pack of 100 tablets, Otsuka America Pharmaceutical Inc., Bristol-Myers Squibb NDC 59148-011-35
Bristol Myers Squibb Manufacturing Company
Class I - Dangerous
CGMP Deviations: A drum of Abilify 30 mg Tablets rejected during the compression stage was not segregated from the other portion of the lot and was inadvertently shipped, packaged and distributed.
0.9% Sodium Chloride Injection USP, 100 mL Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7984-23,
Hospira
Class I - Dangerous
Lack of Assurance of Sterility: There is the potential for solution to leak from the administrative port to the fill tube seal.
Class I - Dangerous
Discoloration: Ethambutol Tablets USP 400 mg have tablets cores that may be discolored.
Class I - Dangerous
Chemical Contamination: The recall has been initiated based on multiple complaints received from pharmacists and consumers reporting that they detected an off-odor, described as moldy, musty or fishy in nature which has been identified as trace levels of Tribromoanisole (TBA) and Trichloroanisole (TCA).
Class I - Dangerous
Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications. All other test specifications were met.
Class I - Dangerous
Lack of Assurance of Sterility; possible loose crimp applied to fliptop vial
Citalopram tablets USP, 40mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupalli, India 502 325, NDC 55111-344-30
Dr. Reddy's Laboratories
Class I - Dangerous
Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell.
Class I - Dangerous
Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.
Citalopram tablets USP, 10mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupalli, India 502 325, NDC 55111-342-30
Dr. Reddy's Laboratories
Class I - Dangerous
Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell.
Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-328-09
Amedra Pharmaceuticals
Class I - Dangerous
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-329-09
Amedra Pharmaceuticals
Class I - Dangerous
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-327-09
Amedra Pharmaceuticals
Class I - Dangerous
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
Citalopram tablets USP, 20mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupalli, India 502 325, NDC 55111-343-30
Dr. Reddy's Laboratories
Class I - Dangerous
Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell.
Class I - Dangerous
Lack of Assurance of Sterility: There is a potential for the solution to leak from the administration port of the primary container.
Class I - Dangerous
Failed Dissolution Specifications; 8-hours for the 18-month stability testing point.