Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johnson Matthey Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, NJ 08066-1742
Reported: April 10, 2019 Initiated: March 5, 2018 #D-1077-2019
Product Description
Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johnson Matthey Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, NJ 08066-1742
Reason for Recall
Microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morphine Sulfate API.
Details
- Recalling Firm
- Johnson Matthey Inc.
- Units Affected
- 169.976 kg
- Distribution
- Nationwide in the US
- Location
- West Deptford, NJ
Frequently Asked Questions
What product was recalled? ▼
Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johnson Matthey Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, NJ 08066-1742. Recalled by Johnson Matthey Inc.. Units affected: 169.976 kg.
Why was this product recalled? ▼
Microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morphine Sulfate API.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 10, 2019. Severity: Moderate. Recall number: D-1077-2019.
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