D-1139-2017 Class III Terminated
FDA drug recall D-1139-2017 was initiated by VistaPharm, Inc. on Aug 17, 2017 and is designated Class III. Reason for recall: Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance The recall status is terminated (terminated Mar 11, 2019). Affected quantity: 3084 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 20, 2017
- Initiation Date
- Aug 17, 2017
- Termination Date
- Mar 11, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3084 bottles
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
Distribution Pattern
Nationwide
Code Information
Lot: 494700 Exp. 10/2018
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1139-2017
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026