Brompheniramine Maleate Injectable Recalled for Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Brompheniramine Maleate 20 mg/ml Injectable due to FDA inspection findings of GMP violations that may impact sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall involving a sterile injectable product where sterility assurance is compromised is classified as Severe (Score 4).
Plain-English summary
The Compounding Pharmacy of America is recalling Brompheniramine Maleate 20 mg/ml Injectable, Vial, Sterile, Room Temperature. The recall is being conducted because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the quality and sterility of the product.
The affected product consists of 44 mL total volume vials. The recall covers all lots distributed nationwide between November 2014 and May 2015. Specific lot codes identified in the recall include 02192015@51 (expiration date 5/20/2015) and 04162015@14 (expiration date 7/15/2015).
Consumers and healthcare providers should stop using the recalled product and contact the recalling firm or their healthcare provider for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Brompheniramine Maleate 20 mg/ml Injectable, Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Injectable
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- All lots distributed between November 2014 and May 2015
- 02192015@51
- 5/20/2015
- 04162015@14
- 7/15/2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 382 recalled by The Compounding Pharmacy of America under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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