Recalls / Class II
Class IID-1077-2019
Product
Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johnson Matthey Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, NJ 08066-1742
- Affected lot / code info
- Lot# B1414-160809, Retest Date AUG 2021
Why it was recalled
Microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morphine Sulfate API.
Recalling firm
- Firm
- Johnson Matthey Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2003 Nolte Dr, N/A, West Deptford, New Jersey 08066-1727
Distribution
- Quantity
- 169.976 kg
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2018-03-05
- FDA classified
- 2019-04-03
- Posted by FDA
- 2019-04-10
- Terminated
- 2021-07-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1077-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.