Ingenus Recalls Irinotecan Hydrochloride Injection Due to Potency Issues
Ingenus Pharmaceuticals is recalling specific lots of Irinotecan Hydrochloride Injection because they had high out-of-specification assay values for potency.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric for significant injury or property damage reports, or high-risk scenarios.
Plain-English summary
Ingenus Pharmaceuticals, LLC is recalling specific lots of Irinotecan Hydrochloride Injection, USP. The affected product is a 100 mg/5 mL (20 mg/mL) single-dose vial intended for intravenous use. The recall involves 34,964 vials distributed nationwide in the USA.
The recall was initiated because the product had high out-of-specification assay value results for potency. The affected lots are 17034-1, 17035-1, and 17036-1, all with an expiration date of 08/19. The product is manufactured for Ingenius Pharmaceuticals, LLC in Orlando, FL, and manufactured by Ingenius Pharmaceuticals, GmbH in Ticino, Switzerland.
Healthcare providers and patients should stop using the affected lots of Irinotecan Hydrochloride Injection. Consumers should check their medication vials for the specific lot numbers and expiration dates listed above. If the product matches the recalled description, it should be returned to the pharmacy or healthcare provider for disposal or replacement.
The recalled product
- Product
- IRINOTECAN HYDROCHLORIDE (IRINOTECAN HYDROCHLORIDE)
- Brand
- IRINOTECAN HYDROCHLORIDE
- Manufacturer
- Ingenus Pharmaceuticals Llc
- Category
- Drug — Antineoplastic
- Hazard
- Affected units
- 34,964
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: 17034-1
- 17035-1
- 17036-1
- Exp. 08/19
UPCs (2)
- 0350742402052
- 0350742401024
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Ingenus Pharmaceuticals Llc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same brand · IRINOTECAN HYDROCHLORIDE
- ModerateHikma Recalls Irinotecan Hydrochloride Injection Due to Container Defect
FDA (Drugs) · 2020-06-24
- ModerateHikma Recalls Irinotecan Hydrochloride Vials Due to Container Defect
FDA (Drugs) · 2020-06-24
- SevereIngenus Recalls Irinotecan Hydrochloride Injection Due to Potency Issues
FDA (Drugs) · 2018-07-11
- SevereFDA Recalls Irinotecan Hydrochloride Injection Due to Incorrect Formulation Calculation
FDA (Drugs) · 2013-11-13
- SevereIrinotecan Hydrochloride Injection Recalled for Incorrect Formulation Calculation
FDA (Drugs) · 2013-11-13
Same manufacturer · Ingenus Pharmaceuticals Llc
See all →- ModerateFDA Recalls Flunisolide Nasal Solution Due to Out-of-Specification Impurities
FDA (Drugs) · 2022-10-26
- ModerateClobetasol Propionate Foam Recalled for CGMP Deviations
FDA (Drugs) · 2022-01-26
- ModerateIngenus Recalls Leucovorin Calcium Injection Due to Crystallization
FDA (Drugs) · 2019-10-23
- LowIngenus Recalls Diclofenac Sodium Topical Solution Due to Leaking Bottles
FDA (Drugs) · 2019-04-03
Same hazard · potency issues
See all →- LowApotex Recalls Aripiprazole Tablets Due to Potential Potency Issues
FDA (Drugs) · 2017-02-15
- ModerateWells Pharmacy Recalls Testosterone Pellets Due to Potency Issues
FDA (Drugs) · 2016-11-16
- SevereWells Pharmacy Recalls Testosterone and Anastrazole Pellets Due to Potency Issues
FDA (Drugs) · 2016-11-16