Agency classClass IIOur severity:Severe FDA (Drugs)·D-0271-2021·Announced 2021-03-03

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
Hazard: sterility-failure
infection-risk
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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 15 products in this recall →

Same manufacturer · Teva Pharmaceuticals USA

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Same hazard · sterility failure