Agency classClass IIOur severity:Severe FDA (Drugs)·D-1576-2015·Announced 2015-09-23

Compounded Injection Recalled for Lack of Sterility Assurance

The Compounding Pharmacy of America is recalling a compounded injection due to FDA-identified GMP violations that impact sterility assurance.

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 and involves a lack of assurance of sterility in an injectable product, which poses a significant risk of serious injury or death from infection.

Plain-English summary

The Compounding Pharmacy of America is recalling Methylcobalamin 7.5 mg/ml + Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 50 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature. The product was distributed nationwide in 188 ml vials. All lots distributed between November 2014 and May 2015 are affected, specifically lot 02272015@17 (expiration 5/28/2015) and lot 04082015@47 (expiration 7/7/2015).

The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility. The agency has determined there is a lack of assurance of sterility for the affected units.

Consumers and healthcare providers should stop using the affected product and contact the recalling firm or their healthcare provider for instructions on return or disposal.

The recalled product

Product: Methylcobalamin 7.5 mg/ml + Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 50 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Compounded Injectable
Hazard: lack-of-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 (5)

All lots distributed between November 2014 and May 2015
02272015@17
5/28/2015
04082015@47
7/7/2015

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

See all →

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Methylcobalamin Injectable Recalled for Sterility Assurance Concerns
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Same hazard · lack of sterility