Brompheniramine Maleate 20 mg/ml Injectable recall: Sterility Concern
Brompheniramine Maleate 20 mg/ml Injectable, Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
Why was Brompheniramine Maleate 20 mg/ml Injectable recalled?
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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?
All lots distributed between November 2014 and May 2015; 02192015@51, 5/20/2015; 04162015@14, 7/15/2015
- Product
- Brompheniramine Maleate 20 mg/ml Injectable, Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
- Recalling firm
- The Compounding Pharmacy of America
- Quantity
- 44 mL total volume
- Distribution
- Nationwide
- Recall date
- September 23, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)