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 Oral Solution
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Defective container: Oral solution leaking from container.
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
Morphine Sulfate Oral Solution, 100 mg/ 5 mL (20 mg/mL), packaged in a 1 oz. bottle containing 30 mL with an oral syringe, Rx Only, Manufactured by: Tris Pharma, Inc. Monmouth Junction, NJ 08852, NDC 27808-082-01
Affected NDC
27808-0082-01
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 27808-0082 |
20 mg/mL | Solution Oral |
Cranbury Pharmaceuticals, LLC | Rx · CII |
- Recalling firm
- Tris Pharma Inc.
- NDC code
- 27808-082-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1126-2017 · 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 Tris Pharma Inc.
All 2017 recalls
Class II · Moderate risk
Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension
Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the active ingredients, hydrocodone and chlorpheniramine, as well as high out-of-specification results for the preservatives.
Class II · Moderate risk
Infants' Ibuprofen
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Class II · Moderate risk
infants* IBUPROFEN
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Class II · Moderate risk
Infants' Ibuprofen
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
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