Drug product
Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only, Manufactured By: /winder Laboratories, LLC, Winder, GA 30680. NDC: 75826-131-01
D-0223-2026
Product summary
- Event
- Event 98077
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 3,528 30 mL Bottles
- Official record key
drug-enforcement:D-0223-2026
Official wording
Reason: Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Code information: Lot 1312405; Exp 09/28/2027
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Unknown
Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.