FDA-Drug2015-11-11Class III
RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 mL (16 fl oz), Rx only. Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC: 0603-9418-58.
Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals
Hazard
Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.
Sold states
U.S. Nationwide
Affected count
61,146 Bottles
Manufactured in
150 Vintage Dr NE, N/A, Huntsville, AL, United States
Products
RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 mL (16 fl oz), Rx only. Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC: 0603-9418-58.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0162-2016Don't want to check this manually?
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