Class II · Moderate risk
Lipo MIC +B12 Methylcobalamin for Injection
Lack of Assurance of Sterility
Methylcobalamin 10 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of assurance of sterility.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Methylcobalamin 10 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Drug: Methylcobalamin
- Recalling firm
- Pharmcore Inc.
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1154-2018 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Methylcobalamin recalls
See all
Class II · Moderate risk
B12 Methylcobalamin for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Methylcobalamin Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Methylcobalamin Injection Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Methylcobalamin 12.5mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Other recalls by Pharmcore Inc.
All 2018 recalls
Class II · Moderate risk
Ipamorelin 9 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach
Lack of assurance of sterility.
Class II · Moderate risk
Ipamorelin 3 mg Lyophilized 1 vial 1109 East Hallandale Beach Blvd. Hallandale Beach
Lack of assurance of sterility.
Class II · Moderate risk
Human Chorionic Gonadotropin 6000 IU Vial Lyophilized 1109 East…
Lack of assurance of sterility.
Class II · Moderate risk
Human Chorionic Gonadotropin 4000 IU Vial Lyophilized 1109 East…
Lack of assurance of sterility.
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