Carnitine Injectable Recalled Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling MIC-PLUS Carnitine Injectable 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, which corresponds to a 'Severe' rating under the rubric for significant injury or property-damage reports or high-risk scenarios, though no specific injuries are reported in the text.
Plain-English summary
The Compounding Pharmacy of America is recalling MIC-PLUS Carnitine Injectable, Multi-Dose Vial, Sterile, Room Temperature. The recall involves 806 ml total volume distributed nationwide between November 2014 and May 2015. Specific lots affected include 02252015@29, 03112015@36, 03192015@18, and 04162015@40.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility. The agency has classified this as a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should stop using the affected product and contact the recalling firm or their healthcare provider for further instructions on disposal or replacement.
The recalled product
- Product
- MIC-PLUS Carnitine 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 (9)
- All lots distributed between November 2014 and May 2015
- 02252015@29
- 5/26/2015
- 03112015@36
- 6/9/2015
- 03192015@18
- 6/17/2015
- 04162015@40
- 7/15/2015
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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