Propranolol Hydrochloride Injection recall: CGMP Deviations
PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Single Dose Vial, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-604-01
Why was Propranolol Hydrochloride Injection recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 6007698, Exp. 03/16
- Product
- PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Single Dose Vial, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-604-01
- Recalling firm
- Fresenius Kabi USA, LLC
- Quantity
- 56,060 vials
- Distribution
- Nationwide and Puerto Rico
- Recall date
- August 27, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)