Lidocaine and Epinephrine Vials Recalled for Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Lidocaine 2% with Epinephrine 1:100,000 vials 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. Per the rubric, FDA Class II recalls involving potential sterility issues in injectable products are assigned a score of 4 (Severe) due to the risk of serious injury or hospitalization from non-sterile administration.
Plain-English summary
The Compounding Pharmacy of America is recalling Lidocaine 2% with Epinephrine 1:100,000 (Buffered) Vials, sterile, 45 ml. The recall is being conducted because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the quality and sterility of the product.
The affected product was distributed nationwide. The recall covers all lots distributed between November 2014 and May 2015. Specific lot codes include 05122015@20 and 5/26/2015.
Healthcare providers and patients should stop using the recalled product and contact the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Lidocaine 2% with Epinephrine 1:100,000 (Buffered) Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Injectable Anesthetic
- 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
- 05122015@20
- 5/26/2015
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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