Why it was recalled
Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.
Product description
Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Pharmaceuticals USA, Inc. NDC 0703-4004-01
Lot numbers, UPCs & expiration codes
Lot # 31328184C, exp. date 11/2021 Lot # 31327686C, exp. date 08/2021 Lot # 31327685C, exp. date 08/2021
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-0309-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 4, 2021
- FDA report date
- Mar 24, 2021
- Quantity
- 1,416 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0309-2021, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 87452
- Address
- 400 Interpace Pkwy
- Code information
- Lot # 31328184C, exp. date 11/2021 Lot # 31327686C, exp. date 08/2021 Lot # 31327685C, exp. date 08/2021
- Postal code
- 07054-1120
- Report date
- Mar 24, 2021
- Product type
- Drugs
- Recall number
- D-0309-2021
- Classification
- Class III
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 1,416 vials
- Termination date
- May 19, 2022
- Reason for recall
- Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Pharmaceuticals USA, Inc. NDC 0703-4004-01
- Distribution pattern
- Distributed Nationwide in the USA.
- Recall initiation date
- Mar 4, 2021
- Initial firm notification
- Letter
- Center classification date
- Mar 19, 2021