Teva Recalls Dacarbazine Injection Due to Sterility Assurance Concerns
Teva Pharmaceuticals is recalling Dacarbazine for Injection USP because manufacturing areas exceeded microbial recovery levels, 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 lack of sterility assurance in injectable products, which poses a significant risk of serious injury or death if administered.
Plain-English summary
Teva Pharmaceuticals USA is recalling Dacarbazine for Injection USP, 200 mg, Single Use Vials. The affected products are identified by Lot # 31326582B (exp. 02/2022) and Lot # 31326964B (exp. 04/2022). The recall involves 50 vials per tray, distributed nationwide in the USA and Puerto Rico.
The recall was initiated because manufacturing areas for these sterile injectable products exceeded acceptance levels for microbial recovery. This condition led to a lack of sterility assurance for the products.
Healthcare providers and patients should stop using the affected lots and contact their pharmacist or the manufacturer for further instructions. The FDA has classified this recall as Class II.
The recalled product
- Product
- Dacarbazine for Injection USP, 200 mg, Single Use Vial (NDC 0703-5075-01), packaged in 10X20 ML Single Use Vials per tray (NDC 0703-5075-03); Rx only, TEVA Pharmaceuticals USA, INC., North Wales, PA 19454.
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Injectable Medication
- Affected units
- 50
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 (4)
- Lot # 31326582B
- exp. date 02/2022
- Lot # 31326964B
- exp. date 04/2022
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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