Why it was recalled
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Product description
Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben 23, 38690 Golsar, Germany Distributed by: West-Word Pharmaceutical Corp. Eatontown, NJ 07724 USA, NDC 0143-9701-01
Lot numbers, UPCs & expiration codes
Lot #: AC0231, AC0235, exp. date 08/2021; AC0237, exp. date 09/2021
Where it was sold
Nationwide within the United States
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-1308-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 11, 2020
- FDA report date
- Jun 24, 2020
- Quantity
- 82,426 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hikma Pharmaceuticals USA Inc.
Original FDA data
Every field from FDA enforcement report D-1308-2020, exactly as published.
Show all FDA fields
- City
- Cherry Hill
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 85831
- Address
- 2 Esterbrook Ln
- Code information
- Lot #: AC0231, AC0235, exp. date 08/2021; AC0237, exp. date 09/2021
- Postal code
- 08003-4002
- Report date
- Jun 24, 2020
- Product type
- Drugs
- Recall number
- D-1308-2020
- Classification
- Class II
- Recalling firm
- Hikma Pharmaceuticals USA Inc.
- Product quantity
- 82,426 vials
- Termination date
- Jun 10, 2021
- Reason for recall
- Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben 23, 38690 Golsar, Germany Distributed by: West-Word Pharmaceutical Corp. Eatontown, NJ 07724 USA, NDC 0143-9701-01
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Jun 11, 2020
- Initial firm notification
- Letter
- Center classification date
- Jun 12, 2020