The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0506-2016·Announced 2015-12-09

Methyfolate Injection Recalled for Potential Penicillin Contamination

Life Science Pharmacy Inc. is recalling Methyfolate Injection due to potential penicillin cross-contamination. The recall covers all lots distributed nationwide.

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 agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with potential for significant injury (penicillin contamination) are classified as Severe.

Plain-English summary

Life Science Pharmacy Inc. is recalling Methyfolate Injection, a prescription compounded product, due to potential cross-contamination with penicillin. The recall applies to all lots of the product.

The product was distributed nationwide. The source text does not specify the number of units affected or the specific dates of distribution.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
METHYLFOLATE Injection, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY

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 (1)

  • All lots

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 23 recalled by Life Science Pharmacy Inc 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 23 products in this recall →

Similar recalls