PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: September 20, 2017 Initiated: August 17, 2017 #D-1139-2017

Product Description

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

Reason for Recall

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

Details

Recalling Firm
VistaPharm, Inc.
Units Affected
3084 bottles
Distribution
Nationwide
Location
Largo, FL

Frequently Asked Questions

What product was recalled?
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. Recalled by VistaPharm, Inc.. Units affected: 3084 bottles.
Why was this product recalled?
Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance
Which agency issued this recall?
This recall was issued by the FDA Drug on September 20, 2017. Severity: Low. Recall number: D-1139-2017.