CLASS II Drug recall · Reported 22 Sep 2021 · FDA Enforcement Report
MIC+Methyl B12 injection Methionine Inositol recalled
Promise Pharmacy is recalling MIC+Methyl B12 injection Methionine Inositol Choline+Methylcobalamin 25 mg/50 mg/50 mg/1, distributed in Arizona, Colorado, Florida, Illinois, New Jersey. The recall was initiated on 30 Jun 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0803-2021
- FDA event ID
- 88662
- Recalling firm
- Promise Pharmacy, Palm Harbor, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Jun 2021
- FDA classified
- 16 Sep 2021
- Reported
- 22 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 30 Jun 2021 | Recall initiated by company | |
| 16 Sep 2021 | Classified by FDA | +78 days |
| 22 Sep 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of processing controls
Product as listed by the FDA
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
Where it was distributed
AZ, CO, FL, IL, NJ
Questions about this recall
Why was it recalled?
Lack of processing controls
Which lots are affected?
Lot# 06152021@2, Exp 09/13/2021
Where was it sold?
AZ, CO, FL, IL, NJ
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Promise Pharmacy
All 53| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Vitamin D3 50,000iu/mL, injection recalled by Promise Pharmacy | Promise Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Glutathione Injection, 200 mg/mL recalled by Promise Pharmacy | Promise Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Sermorelin 9 mg injection recalled by Promise Pharmacy | Promise Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Leucine/Isoleucine/Valine injection, 10mg/10mg/5mg/mL/mL vial recalled | Promise Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Methylcobalamin lyophilized, 10,000 mcg Injection recalled | Promise Pharmacy | Sterility | Nationwide |