Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johnson Matthey Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, NJ 08066-1742

FDA recall notice · announced April 10, 2019 · Johnson Matthey

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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.

Notes

Distribution: Nationwide in the US
Lot/code information: Lot# B1414-160809, Retest Date AUG 2021
Quantity: 169.976 kg
Status: Terminated
Products in this recall event:
- Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johnson Matthey Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, NJ 08066-1742 (D-1077-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.