FDA-Drug2012-07-18Class II
Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL, a) 15 mL Unit Dose Cups (50 unit dose cups per case), b) 473 mL Bottles, C III, Rx Only, Warning May be habit forming, Manufactured by VistaPharm, Largo, FL 33771, NDC a) 66689-023-50, b) NDC 66689-023-16.
VistaPharm, Inc.
Hazard
Impurities/Degradation Products: exceeded specification at 3 month stability testing
Sold states
Nationwide
Affected count
a) 949 Cases, b) 188 bottles
Manufactured in
7265 Ulmerton Rd, Largo, FL, United States
Products
Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL, a) 15 mL Unit Dose Cups (50 unit dose cups per case), b) 473 mL Bottles, C III, Rx Only, Warning May be habit forming, Manufactured by VistaPharm, Largo, FL 33771, NDC a) 66689-023-50, b) NDC 66689-023-16.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1416-2012Don't want to check this manually?
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