Recalls / Class II
Class IID-1407-2014
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
- Affected lot / code info
- JKM7188A
Why it was recalled
Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance.
Recalling firm
- Firm
- Caraco Pharmaceutical Laboratories, Ltd.
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 1150 Elijah McCoy Dr, N/A, Detroit, Michigan 48202-3344
Distribution
- Quantity
- 200 vials
- Distribution pattern
- OH
Timeline
- Recall initiated
- 2014-04-09
- FDA classified
- 2014-06-20
- Posted by FDA
- 2014-07-02
- Terminated
- 2014-09-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1407-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.