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.
Product description
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
Lot numbers, UPCs & expiration codes
Lot # 31328962B, exp. date 04/2022
Where it was sold
Distributed Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0661-2021
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jun 18, 2021
- FDA report date
- Jul 14, 2021
- Quantity
- 10,425 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0661-2021, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 88154
- Address
- 400 Interpace Pkwy
- Code information
- Lot # 31328962B, exp. date 04/2022
- Postal code
- 07054-1120
- Report date
- Jul 14, 2021
- Product type
- Drugs
- Recall number
- D-0661-2021
- Classification
- Class I
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 10,425 vials
- Termination date
- Apr 4, 2022
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Jun 18, 2021
- Initial firm notification
- Letter
- Center classification date
- Jul 15, 2021