Teva Recalls Desmopressin Acetate Injection Due to Sterility Concerns
Teva Pharmaceuticals is recalling Desmopressin Acetate Injection because manufacturing areas exceeded microbial limits, compromising sterility assurance.
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 sterile injectable product with a lack of sterility assurance, which poses a significant risk of serious injury or death if administered.
Plain-English summary
Teva Pharmaceuticals USA is recalling Desmopressin Acetate Injection USP, 4 mcg/mL, 1 mL Preserved Vials. The recall involves 2,577 vials from Lot # 31326669B with an expiration date of 03/2021. The product is distributed nationwide in the USA and Puerto Rico.
The recall was initiated due to a lack of assurance of sterility. Manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery, which means the sterility of these injectable products cannot be guaranteed.
Healthcare providers and patients should stop using the affected product. 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 disposed of according to local regulations.
The recalled product
- Product
- Desmopressin Acetate Injection USP, 4 mcg/mL, 1 mL Preserved Vial (NDC 0703-5051-01), packaged in 10X1 mL Vials per Tray (NDC 0703-5051-03), Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Injectable
- Affected units
- 2,577
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 # 31326669B
- exp. date 03/2021
Distribution
Part of a larger recall action
This product is one of 15 recalled by Teva Pharmaceuticals USA 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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