Clotrimazole Otic Suspension Recalled for Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Clotrimazole 2% Otic Suspension due to FDA inspection findings of GMP violations that may impact sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a sterile medical product where GMP violations impact sterility assurance. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).
Plain-English summary
The Compounding Pharmacy of America is recalling Clotrimazole 2% Otic Suspension, a sterile medication intended for ear use. The recall was initiated following an FDA inspection that identified Good Manufacturing Practice (GMP) violations. These violations raise concerns about the assurance of sterility and potentially impact the overall quality of the product.
The affected product is a 29 mL sterile suspension distributed nationwide. The recall covers all lots distributed between November 2014 and May 2015. Specific lot codes include 05012015@13, 5/31/2015, 05012015@16, and 5/31/2015.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Clotrimazole 2% Otic Suspension, ml, Sterile, Room Temperature, Shake Well, 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 (4)
- All lots distributed between November 2014 and May 2015
- 05012015@13
- 5/31/2015
- 05012015@16
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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