Medications & Supplements/Prescription Drugs

Promise Pharmacy, LLC: MIC+Methyl B12 Injections Recalled for Lack of Processing Controls

Agency Publication Date: September 16, 2021

Summary

Promise Pharmacy, LLC is recalling 57 vials of MIC+Methyl B12 (Methionine, Inositol, Choline, and Methylcobalamin) sterile injections. This prescription medication is being recalled due to a lack of processing controls, which means the pharmacy cannot guarantee the sterility or quality of the injectable drug. This recall affects 10 mL vials distributed to Arizona, Colorado, Florida, Illinois, and New Jersey.

Risk

Injecting a drug that lacks proper processing controls poses a risk of infection or other serious health complications if the product is not sterile. While no injuries have been reported to date, any compromise in the manufacturing process of an injectable medication is a significant safety concern.

What You Should Do

Check your medication vial to see if it is MIC+Methyl B12 injection Methionine Inositol Choline+Methylcobalamin 25 mg/50 mg/50 mg/1 mg/mL in a 10 mL vial.
Locate the lot number on the product label; this recall specifically affects Lot# 06152021@2 with an expiration date of 09/13/2021.
Immediately stop using any vials that match the affected lot number and expiration date.
Contact your healthcare provider or pharmacist for guidance regarding your treatment and to report any adverse effects.
Return any unused vials to Promise Pharmacy or your place of purchase for a refund and contact the manufacturer at 1-888-3PROMIS for further instructions.
For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Refund for unused sterile injection vials.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: MIC+Methyl B12 injection Methionine Inositol Choline+Methylcobalamin (10 mL vial)

Lot Numbers:

06152021@2 (Exp 09/13/2021)

06152021

Date Ranges: Expiration date 09/13/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88662

Status: Resolved

Manufacturer: Promise Pharmacy, LLC

Sold By: Promise Pharmacy

Manufactured In: United States

Units Affected: 57 vials

Distributed To: Arizona, Colorado, Florida, Illinois, New Jersey

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Check your medication vial to see if it is MIC+Methyl B12 injection Methionine Inositol Choline+Methylcobalamin 25 mg/50 mg/50 mg/1 mg/mL in a 10 mL vial.

Locate the lot number on the product label; this recall specifically affects Lot# 06152021@2 with an expiration date of 09/13/2021.

Immediately stop using any vials that match the affected lot number and expiration date.

Contact your healthcare provider or pharmacist for guidance regarding your treatment and to report any adverse effects.

Return any unused vials to Promise Pharmacy or your place of purchase for a refund and contact the manufacturer at 1-888-3PROMIS for further instructions.

For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.