Collagenase Recall Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Collagenase 250 units/ml vials because FDA inspections found GMP violations that may affect sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 the hazard involves a lack of assurance of sterility in a sterile medical product, which poses a significant risk of infection or serious injury.
Plain-English summary
The Compounding Pharmacy of America is recalling Collagenase 250 units/ml, Sterile, Multi-Dose Vials. The product is distributed nationwide and was distributed between November 2014 and May 2015.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations potentially impact the quality and sterility of the product, meaning there is a lack of assurance that the product is sterile.
Healthcare providers and patients should stop using the recalled product. Consumers should contact their healthcare provider for guidance on alternative treatments or further instructions.
The recalled product
- Product
- Collagenase 250 units/ml, Sterile, Multi-Dose Vial, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
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
- 05112015@16
- 8/9/2015
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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