Zinc Chloride Injectable Recalled for Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Zinc Chloride 25mg/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 recall is classified as FDA Class II and involves a sterile injectable product where GMP violations impact sterility assurance, posing a significant risk of infection or injury, which aligns with the 'Severe' criteria for significant injury reports or high-risk defects.
Plain-English summary
The Compounding Pharmacy of America is recalling Zinc Chloride 25mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate. The product is distributed nationwide. The recall involves 130 ml vials from lots distributed between November 2014 and May 2015, specifically identified by the code 05042015@54, 8/2/2015.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations potentially impact the product's quality and sterility, resulting in a lack of assurance of sterility. The agency has classified this as a Class II recall.
Healthcare providers and patients who have this product should stop using it and contact the recalling firm or their healthcare provider for instructions on return or disposal. No specific illnesses or injuries are reported in the source text.
The recalled product
- Product
- Zinc Chloride 25mg/ml Injectable, 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 (3)
- All lots distributed between November 2014 and May 2015
- 05042015@54
- 8/2/2015
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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