FDA-Drug2017-09-20Class III

Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored), 473 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771 ---- NDC 66689-023-16

VistaPharm, Inc.
Hazard

Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance

Sold states
Nationwide
Affected count
3084 bottles
Manufactured in
7265 Ulmerton Rd, N/A, Largo, FL, United States
Products
Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored), 473 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771 ---- NDC 66689-023-16

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1139-2017

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