Why it was recalled
Superpotent Drug: High out of specification assay value results for potency.
Product description
Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC, Orlando, FL 32839-6408; Manufactured by: Ingenius Pharmaceuticals, GmbH Ticino 6917, Switzerland, NDC 50742-402-05.
Lot numbers, UPCs & expiration codes
Lot #: 17034-1, 17035-1, 17036-1; Exp. 08/19
Where it was sold
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-0890-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 8, 2018
- FDA report date
- Jul 11, 2018
- Quantity
- 34964 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ingenus Pharmaceuticals Llc
Original FDA data
Every field from FDA enforcement report D-0890-2018, exactly as published.
Show all FDA fields
- City
- Orlando
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 80254
- Address
- 4190 Millenia Blvd
- Code information
- Lot #: 17034-1, 17035-1, 17036-1; Exp. 08/19
- Postal code
- 32839-6408
- Report date
- Jul 11, 2018
- Product type
- Drugs
- Recall number
- D-0890-2018
- Classification
- Class II
- Recalling firm
- Ingenus Pharmaceuticals Llc
- Product quantity
- 34964 vials
- Termination date
- May 1, 2019
- Reason for recall
- Superpotent Drug: High out of specification assay value results for potency.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC, Orlando, FL 32839-6408; Manufactured by: Ingenius Pharmaceuticals, GmbH Ticino 6917, Switzerland, NDC 50742-402-05.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jun 8, 2018
- Initial firm notification
- Letter
- Center classification date
- Jun 29, 2018