Recalls / Class I
Class ID-0661-2021
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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# 0703-4714-71
- Affected lot / code info
- Lot # 31328962B, exp. date 04/2022
Why it was 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.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 10,425 vials
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2021-06-18
- FDA classified
- 2021-07-15
- Posted by FDA
- 2021-07-14
- Terminated
- 2022-04-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0661-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.