FDAFDA · Food and drugs·Recall number D-1077-2019
Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johnson Matthey Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, NJ 08066-1742
Published April 10, 2019 · Recall initiated: March 5, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morphine Sulfate API.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Johnson Matthey Inc.
- Distributor
- Nationwide in the US
- Lot
- Lot# B1414-160809, Retest Date AUG 2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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