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 Extended-Release Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications: Morphine Sulfate Extended Release Tablets are being recalled due to out of Specification Result noticed for Morphinone Sulfate impurity during 3 month stability analysis and during retain testing.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, NDC 43386-541-01
Affected NDC
43386-0541-01
Compare with the code on your package — it is the most precise check available.
Drug: Morphine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Morphine Sulfate NDC 43386-0541 |
30 mg/1 | Tablet, Film Coated, Extended Release Oral |
Lupin Pharmaceuticals,Inc. | Rx · CII |
- Recalling firm
- Lupin Somerset
- NDC code
- 43386-541-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1214-2018 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. 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 Lupin Somerset
All 2018 recalls
Class III · Low risk
Morphine Sulfate Extended-Release Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Morphine Sulfate Extended-Release Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Morphine Sulfate Extended-Release Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Morphine Sulfate Extended-Release Tablets
Failed Impurities/Degradation Specifications
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