The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1154-2018·Announced 2018-09-05

Pharmcore Recalls Methylcobalamin Vials Due to Sterility Concerns

Pharmcore Inc. is recalling 1,115 vials of Methylcobalamin 10 mg due to a lack of assurance of sterility. The product was 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 FDA classified this recall as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving sterility issues in injectable products which carry significant risk.

Plain-English summary

Pharmcore Inc. is recalling 1,115 vials of Methylcobalamin 10 mg Lyophilized. The recall was initiated because of a lack of assurance of sterility in the product. The affected lots are MTLY-19 (Expiration 10/31/2018) and MTLY-18 (Expiration 8/31/2018).

The recalled product was distributed nationwide. The FDA has classified this recall as Class II, indicating that use of or exposure to the product could cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Consumers and healthcare providers should stop using the recalled vials and contact Pharmcore Inc. or their supplier for further instructions on how to return or dispose of the product.

The recalled product

Product
Methylcobalamin 10 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Manufacturer
Pharmcore Inc.
Category
Drug — Injectable
Hazard
Affected units
1,115

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 (2)

  • Lots: MTLY-19 Exp. 10/31/2018
  • MTLY-18 Exp. 8/31/2018

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 9 recalled by Pharmcore 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 9 products in this recall →

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