Agency classClass IIOur severity:Severe FDA (Drugs)·D-1432-2015·Announced 2015-09-23

Compounded 5-Methyl Tetrahydrofolate Injectable Recalled for Sterility Concerns

The Compounding Pharmacy of America is recalling 5-Methyl Tetrahydrofolate injectable vials due to 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, and the hazard involves a lack of assurance of sterility in an injectable product, which poses a significant risk of serious injury or infection.

Plain-English summary

The Compounding Pharmacy of America is recalling 351 mL of 5-Methyl Tetrahydrofolate 5 mg/ml Injectable, Sterile-Multi-Dose Vials. The product was distributed nationwide between November 2014 and May 2015.

The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations raise a lack of assurance regarding the sterility of the product, potentially impacting its quality.

Consumers and healthcare providers should stop using the affected product and contact the recalling firm or their healthcare provider for instructions on how to return or dispose of the medication.

The recalled product

Product: 5-Methy Tetrahydrofolate 5 mg/ml Injectable, Sterile-Multi-Dose Vial, 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 (20)

All lots distributed between November 2014 and May 2015
02232015@75
5/24/2015
03042015@22
6/2/2015
03172015@44
6/15/2015
03192015@21
6/17/2015
03232015@61
6/21/2015
03272015@49
6/25/2015
04132015@50
7/12/2015
04132015@54
7/12/201
04152015@35
7/14/2015
04162015@12

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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Same hazard · sterility