NuVision Pharmacy Recalls Methylcobalamin Injection Due to Sterility Concerns
NuVision Pharmacy is recalling 32 vials of Methylcobalamin Injection due to lack of assurance of sterility and reports of adverse events.
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 recall is classified as FDA Class II and involves reports of adverse events after injection, which aligns with the 'Severe' criteria for significant injury reports or Class II recalls with adverse outcomes.
Plain-English summary
NuVision Pharmacy, Inc. is recalling 32 vials of Methylcobalamin (Buffered) Injection, 1 mg/mL, 30 mL vial, Stock# 11126. The product was compounded by NuVision Pharmacy in Dallas, TX, and distributed to Florida, Missouri, Utah, and Washington.
The recall was initiated due to a lack of assurance of sterility and reports of adverse events following injection. The affected lot number is N01232013@4, with a 'Do Not Use Beyond' date of January 1, 2014.
Consumers and healthcare providers should stop using the product immediately and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Methylcobalamin (Buffered) Injection,1 mg/mL, 30 mL vial, Stock# 11126, Preservative Free, Compounded by NuVision Pharmacy, Inc., Dallas, TX 75244
- Manufacturer
- NuVision Pharmacy, Inc.
- Hazard
- Affected units
- 32
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 (3)
- Lot Number N01232013@4
- Do Not Use Beyond Date of January 1
- 2014
Distribution
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