Ingenus Recalls Irinotecan Hydrochloride Injection Due to Potency Issues
Ingenus Pharmaceuticals is recalling Irinotecan Hydrochloride Injection because of 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, as it involves a potential for temporary or medically reversible adverse health consequences.
Plain-English summary
Ingenus Pharmaceuticals, LLC is recalling Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vials. The recall involves 14,089 vials distributed nationwide in the USA. The affected lots are 17034-2, 17035-2, and 17036-2, all with an expiration date of 08/19.
The recall was initiated because the drug produced high out-of-specification assay value results for potency. This is classified as a Class II recall by the FDA, indicating a situation where use of, or exposure to, the product might cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare providers and pharmacies should stop using the affected vials and contact Ingenus Pharmaceuticals for further instructions. Patients who have received the medication should consult their healthcare provider if they have concerns.
The recalled product
- Product
- IRINOTECAN HYDROCHLORIDE (IRINOTECAN HYDROCHLORIDE)
- Brand
- IRINOTECAN HYDROCHLORIDE
- Manufacturer
- Ingenus Pharmaceuticals Llc
- Category
- Drug — Antineoplastic
- Hazard
- Affected units
- 14,089
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 #: 17034-2
- 17035-2
- 17036-2
- 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
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- SevereIngenus Recalls Irinotecan Hydrochloride Injection Due to Potency Issues
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- SevereIrinotecan Hydrochloride Injection Recalled for Incorrect Formulation Calculation
FDA (Drugs) · 2013-11-13
- SevereFDA Recalls Irinotecan Hydrochloride Injection Due to Incorrect Formulation Calculation
FDA (Drugs) · 2013-11-13
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