US Compounding Recalls Methylcobalamin Vials Due to Sterility Assurance Concerns
US Compounding Inc is recalling 265 vials of Methylcobalamin injection due to deficient practices that may impact sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls involving significant risks such as sterility assurance failures in injectable products are classified as Severe.
Plain-English summary
US Compounding Inc is recalling 265 vials of Methylcobalamin (12.5 mg/mL), 2.5 mL Multi-Dose Vial, For IM or SC Injection. The product is compounded by US Compounding Pharmacy in Conway, Arkansas, and carries the NDC 62295-3251-04.
The recall is being conducted because of deficient practices that may have an impact on sterility assurance. The firm is recalling all sterile preparations that are within expiry due to these concerns. The affected lot numbers are 20152105@38 with a best-use-by date of 11/17/2015, and 20152705@34 with a best-use-by date of 11/23/2015.
The product was distributed nationwide. Consumers and healthcare providers should stop using the affected vials and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Methylcobalamin (12.5 mg/mL), 2.5 mL Multi-Dose Vial, For IM or SC Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3251-04.
- Manufacturer
- US Compounding Inc
- Category
- Drug — Injectable
- Hazard
- Affected units
- 265
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 Numbers: 20152105@38 BUD: 11/17/2015
- 20152705@34 BUD: 11/23/2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 59 recalled by US Compounding Inc 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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