FDA Recalls Methylcobalamin Vials Due to Lack of Sterility Assurance
Pharmacy Plus, Inc. is recalling Methylcobalamin 5,000mcg/ml vials due to lack of assurance of sterility. The recall affects 36 vials distributed in Mississippi.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the hazard involves a lack of sterility assurance in a parenteral product, which poses a significant risk of infection or serious injury.
Plain-English summary
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling Methylcobalamin 5,000mcg/ml, 1mL single-dose vials. The recall was initiated due to a lack of assurance of sterility. The affected product is Lot# 396814 with a use-by date of 12-14-16.
The recall involves 36 vials that were distributed in Mississippi. The product is a prescription (Rx) compounded medication.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Methylcobalamin 5,000mcg/ml, 1mL SDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402
- Manufacturer
- Pharmacy Plus, Inc. dba Vital Care Compounder
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 36
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 (2)
- Lot# 396814
- Use by 12-14-16
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 21 recalled by Pharmacy Plus, Inc. dba Vital Care Compounder under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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