Methylcobalamin Injection Recalled for Lack of Sterility Assurance
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling 514 vials of methylcobalamin injection solution. FDA inspection found manufacturing conditions that do not assure sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II classification indicates potential for serious health consequences. However, no illnesses, injuries, or deaths have been reported in the source. The hazard—lack of sterility assurance in injectable products—poses risk of infection but remains theoretical. Per the rubric, unresolved theoretical hazards with no reported harm score at most 3.
Plain-English summary
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling 514 vials of METHYLCOBALAMIN PF 1 ML Injection Solution, 5,000 MCG/ML, in 1 mL vials. The product is distributed under the Vital Care Compounder brand at 115 S. 40th Ave., Hattiesburg, MS 39402.
The recall was initiated because the FDA determined during an inspection that the products were manufactured in a manner that does not assure sterility. This means the agency cannot guarantee that these injectable products are free from microbial contamination.
The affected product was distributed to Alabama, Louisiana, Mississippi, and Tennessee. The recalled lots are Lot 57997 (Beyond Use Date 02/25/2023) and Lot 64941 (Beyond Use Date 03/08/2023).
Patients and healthcare providers who have received or dispensed the recalled product should discontinue use immediately and contact Pharmacy Plus, Inc. dba Vital Care Compounder for instructions on return or proper disposal.
The recalled product
- Product
- METHYLCOBALAMIN PF 1 ML Injection Solution 5,000 MCG/ML Solution, 1 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
- Manufacturer
- Pharmacy Plus, Inc. dba Vital Care Compounder
- Category
- Drug — Injectable
- Hazard
- sterility-failure
- infection-risk
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 (4)
- Lot: 57997
- BUD: 02/25/2023
- 64941
- BUD: 03/08/2023
Distribution
Distributed in 4 states:
- AL
- LA
- MS
- TN
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