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

FDA recall notice · announced September 20, 2017 · Vistapharm

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

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

Notes

Distribution: Nationwide
Lot/code information: Lot: 494700 Exp. 10/2018
Quantity: 3084 bottles
Status: Terminated
Products in this recall event:
- 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 (D-1139-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.