Teva Recalls Toposar Etoposide Injection Due to Sterility Assurance Issues
Teva Pharmaceuticals is recalling Toposar (etoposide) injection vials because manufacturing areas exceeded microbial acceptance 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. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization reports are rated Severe (4). While specific injury reports are not detailed in the provided text, the failure of sterility assurance in an injectable drug presents a significant risk of serious harm (sepsis/infection), aligning with the Severe criteria for high-risk contamination in injectables.
Plain-English summary
Teva Pharmaceuticals USA is recalling 4,806 vials of Toposar (etoposide injection USP), 1 gram/50 mL (20 mg/mL), 50 mL Multiple-dose Vial. The affected product is identified by Lot # 31327600B with an expiration date of 08/2022. The product was distributed nationwide in the USA and Puerto Rico.
The recall was initiated due to a lack of assurance of sterility. Specifically, manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery, which led to a lack of sterility assurance for these sterile injectable products.
Healthcare providers and patients should stop using the affected vials and contact Teva Pharmaceuticals or their supplier for further instructions. This is a prescription-only medication.
The recalled product
- Product
- Toposar (etoposide injection USP), 1 gram/50 mL (20 mg/mL), 50 mL Multiple-dose Vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-5657-01.
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Injectable
- Affected units
- 4,806
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 # 31327600B
- exp. date 08/2022
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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