Downing Labs Recalls Methylcobalamin Injection Due to Sterility Concerns
Downing Labs, LLC is recalling 315 vials of Methylcobalamin Injection Buffered 5mg/mL due to a lack of assurance of sterility. The product was distributed nationwide and internationally.
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 involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious health consequences such as infection.
Plain-English summary
Downing Labs, LLC is recalling 315 vials of Methylcobalamin Injection Buffered 5mg/mL, 30mL vial, Rx only. The recall is being conducted due to a lack of assurance of sterility. The affected product is identified by the recall number D-0384-2016 and includes all lots.
The recalled 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 FDA has classified this recall as Class II.
Consumers and healthcare providers should stop using the affected product and contact Downing Labs, LLC at 1-800-914-7435 for further instructions or to arrange for a return.
The recalled product
- Product
- Methylcobalamin Injection Buffered 5mg/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
- Hazard
- Affected units
- 315
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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