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.
Oxycodone HCl Oral Concentrate
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Labeling: Label Mix up; product labeled as Morphine Sulfate 20 mg/mL actually contained OxyCODONE HCl 20 mg/mL
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
Oxycodone HCl Oral Concentrate, 20 mg/mL, Rx (C-II) Packaged and labeled as Morphine Sulfate 20 mg/mL, Mfg: Lannett Co. Inc., Re-Packaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfr: Cody Laboratories Inc., Cody, WY NDC 00527-1426-36
Affected NDC
0527-1426-36
Compare with the code on your package — it is the most precise check available.
Drug: Morphine
- Recalling firm
- Shamrock Medical Solutions Group LLC
- NDC code
- 00527-1426-36
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1447-2014 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. 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 Shamrock Medical Solutions Group LLC
All 2011 recalls
Class II · Moderate risk
Docusate Calcium Softgel Capsules
Labeling: Label Mix up; product labeled to contain Docusate Sodium 240mg instead of Docusate Calcium 240mg
Class II · Moderate risk
Sulfamethoxazole and Trimethoprim Tablets
Labeling: Label Mix up; product labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg instead of Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets
Labeling: Label Mix up; product labeled to contain Nebivolol tablets actually contained Pramipexole Dihydrochloride tablets
Class I · High risk
metFORMIN ER Tablets
Labeling: Label Mix up; product labeled did not indicated Extended Release
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