RXQ Compounding Recalls Methylcobalamin Injectable Solution Due to Sterility Concerns
RXQ Compounding LLC is recalling Methylcobalamin 1 mg/mL Injectable Solution because the product lacks assurance of sterility.
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 FDA classified this recall as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving injectable products where sterility is a critical safety factor.
Plain-English summary
RXQ Compounding LLC is voluntarily recalling Methylcobalamin 1 mg/mL (MDV) Injectable Solution, 10 mL per vial (NDC: 70731-0915-10). The recall was initiated because the product lacks assurance of sterility. The affected product was distributed nationwide in the United States.
The recall covers all lots of the product within their expiration dates. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare providers and patients should discontinue use of the recalled product. Consumers should contact their healthcare provider for guidance on alternative treatments or further instructions.
The recalled product
- Product
- METHYLCOBALAMIN 1 MG/ML (MDV) INJECTABLE SOLUTION, 10 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0915-10
- Manufacturer
- RXQ Compounding LLC
- Category
- Drug — Injectable Solution
- Hazard
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 (1)
- All lots within expiry
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 86 recalled by RXQ Compounding LLC 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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