Teva Recalls Haloperidol Decanoate Injection Due to Sterility Concerns
Teva Pharmaceuticals is recalling specific lots of Haloperidol Decanoate Injection because the company cannot guarantee 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 involves a sterile injectable medication where a lack of sterility assurance poses a significant risk of serious health consequences, meeting the criteria for a Severe rating.
Plain-English summary
Teva Pharmaceuticals USA is recalling 7,020 vials of Haloperidol Decanoate Injection, USP 100 mg/mL, 1 mL Single Dose Vials. The recall was initiated due to a lack of assurance of sterility for the affected product.
The recalled product includes Lot # 31325394C with an expiration date of 09/2021 and Lot # 31327161B with an expiration date of 04/2022. The product was distributed nationwide. The NDC number for the recalled product is 0703-7131-03.
Healthcare providers and patients should stop using the affected vials and contact their pharmacist or the manufacturer for instructions on how to return the product.
The recalled product
- Product
- Haloperidol Decanoate Injection, USP 100 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA NDC 0703-7131-03
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Injectable
- Affected units
- 7,020
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 (3)
- Lot # 31325394C
- exp. date 09/2021 Lot # 31327161B
- exp. date 04/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 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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