The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0443-2019·Announced 2019-02-20

Promise Pharmacy Recalls Methylcobalamin Injections Due to Sterility Concerns

Promise Pharmacy, LLC is recalling 704 vials of Methylcobalamin 10,000 mcg Injection due to a lack of sterility assurance. The product was distributed nationwide in the USA.

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. According to the severity rubric, an FDA Class II recall with potential for adverse health consequences (lack of sterility assurance) corresponds to a score of 4 (Severe), as it does not meet the criteria for Class I (Critical) but exceeds the threshold for High (3) due to the specific agency classification and nature of the defect.

Plain-English summary

Promise Pharmacy, LLC is recalling 704 vials of Methylcobalamin lyophilized, 10,000 mcg Injection. The recall is being conducted because of a lack of sterility assurance in the product. The affected lots are 08032018@3, 08272018@6, 09142018@4, and 10012018@3, with expiration dates ranging from January 30, 2019, to March 30, 2019.

The recalled product was distributed nationwide in the United States. The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Consumers who have purchased or received this product should stop using it and contact their healthcare provider or the recalling firm for further instructions on how to return or dispose of the medication.

The recalled product

Product
Methylcobalamin lyophilized, 10,000 mcg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Manufacturer
Promise Pharmacy, LLC
Category
Drug — Compounded Injectable
Hazard
Affected units
704

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 (4)

  • Lots: 08032018@3 BUD: 01/30/2019
  • 08272018@6 BUD: 2/23/2019
  • 09142018@4 BUD: 3/13/2019
  • 10012018@3 BUD: 3/30/2019

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 51 recalled by Promise Pharmacy, LLC 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 51 products in this recall →

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