Downing Labs Recalls Cyanocobalamin Injectable Due to Sterility Concerns
Downing Labs, LLC is recalling Cyanocobalamin Buffered Injectable 3mg/mL vials because the company cannot ensure the product is sterile.
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 hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of infection or serious injury.
Plain-English summary
Downing Labs, LLC is recalling Cyanocobalamin Buffered Injectable 3mg/mL, 30mL vials. The recall is being conducted because the company lacks assurance of the sterility of the product. The recall includes 20 vials and applies to all lots.
The affected product was distributed nationwide in the United States as well as in Australia, Brazil, the Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, the Philippines, Singapore, Thailand, Trinidad and Tobago, and Taiwan. The product is prescription-only.
Consumers and healthcare providers should stop using the recalled product and contact Downing Labs, LLC at 1-800-914-7435 for further instructions.
The recalled product
- Product
- Cyanocobalamin Buffered Injectable 3mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
- Manufacturer
- Downing Labs, LLC
- Category
- Drug — Injectable
- Affected units
- 20
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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 48 recalled by Downing Labs, 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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