Calmme Injectable Recalled Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Calmme Injectable multi-dose vials because an FDA inspection identified 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 with GMP violations impacting sterility, which aligns with the rubric for Severe severity (FDA Class II with potential for significant injury).
Plain-English summary
The Compounding Pharmacy of America is recalling Calmme Injectable, a sterile multi-dose vial product, due to a lack of assurance of sterility. The recall covers 296 ml of product distributed nationwide between November 2014 and May 2015.
An FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the quality and sterility of the product. The agency has classified this recall as Class II.
Healthcare providers and patients who have received or possess this product should stop using it and contact the recalling firm or their healthcare provider for instructions on return or disposal.
The recalled product
- Product
- Calmme 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 (7)
- All lots distributed between November 2014 and May 2015
- 03232015@1
- 6/21/2015
- 04222015@8
- 7/21/2015
- 05052015@7
- 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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