The Recall Desk
SevereFDA (Drugs)·D-0467-2019·Announced 2019-02-20

Promise Pharmacy Recalls MIC B12 Injection Due to Sterility Concerns

Promise Pharmacy, LLC is recalling MIC B12+L-Carnitine+Chromium injections due to a lack of sterility assurance. The recall covers 64 vials 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, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk scenarios.

Plain-English summary

Promise Pharmacy, LLC is recalling 64 vials of MIC B12+L-Carnitine+Chromium injection (Methionine Inositol Choline Methylcobalamin+L-Carnitine+Chromium). The product is a prescription-only injection with a concentration of 25mg/50mg/50mg/1mg/100mg/0.4mcg/ml in 10mL vials. The specific lot number is 10102018@1 with a beyond-use date of 1/8/2019.

The recall was initiated due to a lack of sterility assurance. The affected products were distributed nationwide in the USA.

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
MIC B12+L-Carnitine+Chromium injection, Methionine Inositol Choline Methylcobalamin+L-Carnitine+Chromium, 25mg/50mg/50mg/1mg/100mg/0.4mcg/ml, 10mL, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Hazard
Affected units
64

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)

  • Lot: 10102018@1 BUD: 1/8/2019

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 →