Promise Pharmacy Recalls Methylcobalamin Injection Due to Sterility Concerns
Promise Pharmacy is recalling 252 vials of Methylcobalamin Injection due to a lack of sterility assurance. The product was distributed nationwide.
What this means for you
Illness, injury, or structural failure has been reported. 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 rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe. While specific injury reports are not detailed in the source, the agency classification of Class II for a sterile injection product aligns with the Severe criteria for significant potential harm.
Plain-English summary
Promise Pharmacy, LLC is recalling 252 vials of Methylcobalamin lyophilized 50,000 mcg Injection, Rx Only. The recall is being conducted due to a lack of sterility assurance in the product.
The affected lots are 08212018@11 with a best-use date of 12/19/2018, and 10012018@1 with a best-use date of 1/29/2019. The product was distributed nationwide in the USA.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for further instructions.
The recalled product
- Product
- Methylcobalamin lyophilized 50,000 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
- 252
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: 08212018@11 BUD: 12/19/2018
- 10012018@1 BUD: 1/29/2019
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.
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