MIC+Methyl B12 Injection Recalled for Lack of Processing Controls
Promise Pharmacy is recalling MIC+Methyl B12 injection (57 vials, Lot# 06152021@2) distributed across five states due to lack of processing controls that may affect product quality and safety.
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 source indicates this is an FDA Class II recall. Class II recalls, particularly for sterile injectable drugs with manufacturing control defects, pose significant risk of serious adverse health consequences including potential infection or loss of therapeutic efficacy, meeting the Severe criterion.
Plain-English summary
Promise Pharmacy, LLC is recalling MIC+Methyl B12 injection, a prescription sterile injectable product containing Methionine, Inositol, Choline, and Methylcobalamin (25 mg/50 mg/50 mg/1 mg/mL). The recall affects 57 vials with Lot# 06152021@2 (expiration date 09/13/2021) distributed to Arizona, Colorado, Florida, Illinois, and New Jersey.
The recall is due to lack of processing controls. The manufacturer failed to implement adequate controls during production, which may compromise the product's sterility, potency, or safety.
Healthcare providers and patients who have this product should stop using it immediately and contact Promise Pharmacy at 1-888-3PROMIS for instructions on return or disposal. Patients should consult their healthcare provider regarding alternative treatments.
The recalled product
- Product
- MIC+Methyl B12 injection Methionine Inositol Choline+Methylcobalamin 25 mg/50 mg/50 mg/1 mg/mL, 10 mL vial sterile, Rx only, Promise Pharmacy 31818 US Hwy 19N Palm Harbor FL 34684 1-888-3PROMIS
- Manufacturer
- Promise Pharmacy, LLC
- Category
- Drug — Injectable / Compounded
- Affected units
- 57
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)
- Lot# 06152021@2
- Exp 09/13/2021
Distribution
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