Magnesium Chloride Injection Recalled for Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Magnesium Chloride 200 mg/ml Injection due to FDA inspection findings regarding GMP violations and lack of sterility assurance.
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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in injectable drugs) are categorized as Severe (Score 4), particularly when structural or quality defects are identified by inspection.
Plain-English summary
The Compounding Pharmacy of America is recalling Magnesium Chloride 200 mg/ml (20%) Injection, Multi-Dose Vial, Sterile, Refrigerate. The recall involves 924 ml of product distributed nationwide between November 2014 and May 2015. Specific lots affected include 04202015@79, 04072015@24, 04222015@10, and 05052015@4.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility. The agency has classified this as a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and patients who have received this product should stop using it and contact the recalling firm or their healthcare provider for instructions on return or disposal. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Magnesium Chloride 200 mg/ml (20%) Injection, Multi-Dose Vial, Sterile, Refrigerate, 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 (9)
- All lots distributed between November 2014 and May 2015
- 04202015@79
- 7/19/2015
- 04072015@24
- 7/6/2015
- 04222015@10
- 7/21/2015
- 05052015@4
- 8/3/2015
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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