Caraco Recalls Gemcitabine Injection Due to Sterility Assurance Concerns
Caraco Pharmaceutical Laboratories is recalling 200 vials of Gemcitabine For Injection USP due to a lack of assurance of sterility.
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 and involves a lack of sterility assurance for an intravenous medication, which poses a significant risk of serious injury or death if administered.
Plain-English summary
Caraco Pharmaceutical Laboratories, Ltd. is recalling 200 vials of Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, Sterile Single Use Vial. The product is identified by NDC 47335-154-40 and code JKM7188A. The recall is limited to distribution in Ohio.
The recall was initiated due to a lack of assurance of sterility. The source text notes that a particle excursion for a different batch of the same product may lead to this lack of sterility assurance. No specific illnesses or injuries are reported in the source text.
Healthcare providers and patients should stop using the affected product and contact their healthcare provider for further instructions. The FDA has classified this recall as Class II.
The recalled product
- Product
- Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, Sterile Single Use Vial, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd, Gujarat, India, NDC 47335-154-40
- Manufacturer
- Caraco Pharmaceutical Laboratories, Ltd.
- Category
- Drug — Antineoplastic
- Affected units
- 200
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 (1)
- JKM7188A
Distribution
Distributed in 1 state:
Related recalls
Same manufacturer · Caraco Pharmaceutical Laboratories, Ltd.
See all →- ModerateCaraco Recalls Cephalexin Capsules Due to Manufacturing Deviations
FDA (Drugs) · 2014-08-13
- ModerateCaraco Recalls Cephalexin Capsules Due to Manufacturing Practice Deviations
FDA (Drugs) · 2014-08-13
- ModerateCaraco Recalls Venlafaxine Hydrochloride Extended-Release Tablets for Dissolution Failures
FDA (Drugs) · 2014-07-09
- LowCaraco Recalls Cetirizine Hydrochloride Chewable Tablets Due to Impurities
FDA (Drugs) · 2014-05-07
- ModerateCaraco Recalls Venlafaxine Hydrochloride Extended-Release Tablets for Dissolution Failures
FDA (Drugs) · 2014-05-07
Same hazard · sterility
See all →- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- SeverePrestige Recalls Clear Eyes Maximum Itchy Eye Relief Due to Sterility Concerns
FDA (Drugs) · 2026-08-19
- SevereROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- HighROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- SevereFDA Recalls ROHTO OPTIC GLOW Eye Drops Over Sterility Concerns
FDA (Drugs) · 2026-07-29