Recalls / Class II
Class IID-1881-2019
Product
Cisplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ 08066-1742 (856) 384-7001
- Affected lot / code info
- Lot #: B0101-161102, Exp. Dec 2021
Why it was recalled
cGMP Deviations: Potential glass contamination
Recalling firm
- Firm
- Johnson Matthey Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2003 Nolte Dr, West Deptford, New Jersey 08066-1727
Distribution
- Quantity
- 26625 grams
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2019-08-29
- FDA classified
- 2019-09-25
- Posted by FDA
- 2019-10-02
- Terminated
- 2022-01-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1881-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.