Lidocaine 1% Injection Recalled Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Lidocaine 1% Injection because FDA inspections found GMP violations that may affect 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 with potential for adverse health consequences (such as sterility failures in injectable drugs) are categorized as Severe.
Plain-English summary
The Compounding Pharmacy of America is recalling Lidocaine 1% Injection, 160 ml vials, distributed nationwide. The recall was initiated after FDA inspections identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility.
The recall covers all lots distributed between November 2014 and May 2015. Specific lot codes include 04062015@78, with a date of 7/5/2015. The agency has classified this as a Class II recall, indicating a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and patients should stop using the affected product and contact the recalling firm for instructions on return or disposal. Consumers should verify lot numbers against the recall notice to determine if their specific product is affected.
The recalled product
- Product
- Lidocaine 1% Injection, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Injectable
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
- 04062015@78
- 7/5/2015
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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