American Regent Recalls Cyanocobalamin Injections Due to Particulate Matter
American Regent, Inc. is recalling specific lots of Cyanocobalamin injections due to the presence of particulate matter, including hair, glass, and paraformaldehyde.
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 recall is classified as FDA Class II, and the presence of glass and particulate matter in an injectable drug poses a significant risk of injury, meeting the criteria for a Severe rating.
Plain-English summary
American Regent, Inc. is recalling Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), for intramuscular or subcutaneous use. The recall affects 26,450 vials, including 10 mL Multi-Dose Vials (NDC 0517-0032-01) and 25x10 mL Multi-Dose Vials (NDC 0517-0032-25). The affected product is identified by Lot # 25082 with an expiration date of 3/31/2027.
The recall was initiated because the product was found to be contaminated with particulate matter. The specific contaminants identified include hair, glass, and/or paraformaldehyde. The product was distributed nationwide within the United States.
Healthcare providers and patients should stop using the affected product immediately. Consumers should check their medication for the specific lot number and expiration date listed above. If the product matches the recalled lot, it should be returned to the pharmacy or healthcare provider for disposal or replacement.
The recalled product
- Product
- CYANOCOBALAMIN (CYANOCOBALAMIN)
- Brand
- CYANOCOBALAMIN
- Manufacturer
- American Regent, Inc.
- Category
- Drug — Injectable Vitamin
- Affected units
- 26,450
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 #: 25082
- Exp. Date: 3/31/2027.
UPCs (2)
- 0305170031251
- 0305170032258
Distribution
Distributed nationwide across the United States.
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