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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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:
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