FDA-Drug2025-12-17Class III

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

Winder Laboratories, LLC
Hazard

Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.

Sold states
U.S. Nationwide
Affected count
3,528 30 mL Bottles
Manufactured in
716 Patrick Industrial Ln, N/A, Winder, GA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0223-2026

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