FDA Drug recall D-0728-2018
Methylcobalamin for injection, 1mg/mL and 10 mg/mL, Sterile injectable, Vitalab Pharmacy, Inc
- FDA Drug
- Class II
- terminated
- Published 2018-05-16
On 2018-05-16 the FDA classified a Class II recall of Methylcobalamin for injection, 1mg/mL and 10 mg/mL, Sterile injectable, Vitalab Pharmacy, Inc by Vitalab Pharmacy, citing lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0728-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-24 |
| Published | 2018-05-16 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Vitalab Pharmacy |
| Distribution | US |
Product
Methylcobalamin for injection, 1mg/mL and 10 mg/mL, Sterile injectable, Vitalab Pharmacy, Inc
Reason
Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.
Identifiers
| code_info | Lot #: 02122018@77, 03092018@52,02122018@76,03142018@32, 01312018@40, 12282017@31, 01232018@17, 03052018@54, 03082018@3…Lot #: 02122018@77, 03092018@52,02122018@76,03142018@32, 01312018@40, 12282017@31, 01232018@17, 03052018@54, 03082018@39 02082018@55, 02082018@56, 03062018@69, 02052018@56,03122018@62 02072018@95, 03122018@63, 02072018@96, 03122018@64, 02072018@97; Exp 05/06/2018-09/10/2018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0728-2018%22
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