Agency classClass IIOur severity:Severe FDA (Drugs)·D-1580-2015·Announced 2015-09-23

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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: sterility
gmp-violation

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.

See all 382 products in this recall →

Same manufacturer · The Compounding Pharmacy of America

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Same hazard · sterility