Class I · High risk
Morphine Sulfate Injection
Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
Morphine Sulfate USP Milled
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morphine Sulfate API.
Cause type: Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.
What was recalled
Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johnson Matthey Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, NJ 08066-1742
Drug: Morphine
- Recalling firm
- Johnson Matthey Inc.
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1077-2019 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Morphine recalls
See all
Class III · Low risk
Morphine Sulfate Oral Solution 100 mg / 5 mL
Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Class II · Moderate risk
Morphine Sulfate 5 mg per 0.25 mL Oral Syringe
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Class II · Moderate risk
Morphine Sulfate Extended-Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Morphine Sulfate Extended-Release Tablets 30 mg
Failed Impurities/Degradation Specification
Other recalls by Johnson Matthey Inc.
All 2018 recalls
Class II · Moderate risk
Oxaliplatin Active Pharmaceutical Ingredient
cGMP Deviations: Potential glass contamination
Class II · Moderate risk
Cisplatin Active Pharmaceutical Ingredient
cGMP Deviations: Potential glass contamination
Class II · Moderate risk
Fentanyl Citrate Active Pharmaceutical Ingredient
cGMP Deviations: Potential glass contamination
Class III · Low risk
Remifentanil HCl active pharmaceutical ingredient
Failed Impurities/Degradation Specifications: Unknown impurity above specification limits.
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