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Class III: unlikely to cause harmTerminated

VistaPharm Hydrocodone Bitartrate and Acetaminophen Recall

Hydrocodone Bitartrate and Acetaminophen Oral Solution 7

VistaPharm, Inc. · Largo, FL

Risk level
Class III
Reported by FDA
Sep 20, 2017
Recall ID
D-1139-2017
Check your lot numberHow we source this data

Summary

VistaPharm recalled Hydrocodone Bitartrate and Acetaminophen starting Aug 17, 2017. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-1139-2017 on Sep 20, 2017. Reason: Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance. Status: Terminated.

Why it was recalled

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

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

Lot numbers, UPCs & expiration codes

Lot: 494700 Exp. 10/2018

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1139-2017
Classification
Class III
Status
Terminated
Recall initiated
Aug 17, 2017
FDA report date
Sep 20, 2017
Quantity
3084 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
VistaPharm, Inc.

Original FDA data

Every field from FDA enforcement report D-1139-2017, exactly as published.

Show all FDA fields
City
Largo
State
FL
Status
Terminated
Country
United States
Event ID
77998
Address
7265 Ulmerton Rd
Code information
Lot: 494700 Exp. 10/2018
Postal code
33771-4809
Report date
Sep 20, 2017
Product type
Drugs
Recall number
D-1139-2017
Classification
Class III
Recalling firm
VistaPharm, Inc.
Product quantity
3084 bottles
Termination date
Mar 11, 2019
Reason for recall
Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Nationwide
Recall initiation date
Aug 17, 2017
Initial firm notification
Letter
Center classification date
Sep 12, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1139-2017, published Sep 20, 2017. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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