Downing Labs Recalls Zinc Sulfate Injection Due to Sterility Concerns
Downing Labs, LLC is recalling 74 vials of Zinc Sulfate Injection 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 medication, which poses a significant risk of infection or serious adverse health consequences.
Plain-English summary
Downing Labs, LLC is recalling 74 vials of Zinc Sulfate (Elemental) Injection, 10mg/mL, 30 mL vial, Rx only. The recall is being conducted due to a lack of assurance of sterility. The product is prescription-only and 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 recall covers all lots of the affected product. 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 stop using the recalled product and contact Downing Labs, LLC at 1-800-914-7435 for further instructions. Consumers should not use the product and should return it to the pharmacy or healthcare provider where it was obtained.
The recalled product
- Product
- Zinc Sulfate (Elemental) Injection, 10mg/mL, 30 mL 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 Medication
- Affected units
- 74
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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