Mannitol 5% Injectable Recalled Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Mannitol 5% Injectable vials because FDA inspections found 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.
Plain-English summary
The Compounding Pharmacy of America is recalling Mannitol 5% Injectable, Multi-Dose Vials. The recall involves 425 ml total of the sterile, room-temperature product distributed nationwide between November 2014 and May 2015. Specific lots include 04072015@30 (expiration 7/6/2015) and 05042015@23 (expiration 8/2/2015).
The recall was initiated due to a lack of assurance of sterility. FDA inspections identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility. The agency has classified this recall as Class II.
Healthcare providers and patients should stop using the affected Mannitol 5% Injectable vials and contact the recalling firm for further instructions. Consumers should verify lot numbers against the recall notice to determine if their product is affected.
The recalled product
- Product
- Mannitol 5% Injectable, Multi-Dose 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
- 04072015@30
- 7/6/2015
- 05042015@23
- 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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