Topotecan Injection 4 mg/4mL recall: Particulate Matter
Topotecan Injection 4 mg/4mL (1 mg/mL), Single-Dose vial, Teva Pharmaceuticals USA, Inc. North Whales, PA 19454, Carton NDC# 0703-4714-01, Vial NDC#…
Why was Topotecan Injection 4 mg/4mL recalled?
Presence of Particulate Matter: Complaint received of a glass particle observed inside the vial. The vial was returned to Teva for further analysis where two other particulates were found and identified as one (1) grey silicone particle and one (1) translucent, colorless cotton fiber.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 31328962B, exp. date 04/2022
- Product
- Topotecan Injection 4 mg/4mL (1 mg/mL), Single-Dose vial, Teva Pharmaceuticals USA, Inc. North Whales, PA 19454, Carton NDC# 0703-4714-01, Vial NDC#…
- Recalling firm
- Teva Pharmaceuticals USA
- Quantity
- 10,425 vials
- Distribution
- Distributed Nationwide in the USA
- Recall date
- July 14, 2021
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (drug)