Reported Jul 18, 2012 · Terminated
Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL, a) 15 mL Unit Dose Cups (50 unit dose…
VistaPharm, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: VistaPharm, Inc. · 7265 Ulmerton Rd · Largo, FL · 33771-4809
Is this the product you have?
4 of 4 products
| # | Product as published |
|---|---|
| 1 | 15 mL Unit Dose Cups (50 unit dose cups per case) |
| 2 | 473 mL Bottles, C III, Rx Only, Warning May be habit forming, Manufactured by VistaPharm, Largo, FL 33771, NDC |
| 3 | 66689-023-50 |
| 4 | NDC 66689-023-16. |
- Lot codes and dates
Lot #'s a) 251400Exp 07/13b) 251500 Exp 07/13
- Amount recalled
- a) 949 Cases, b) 188 bottles
Where it was sold
- Nationwide
Why it was recalled
Impurities/Degradation Products: exceeded specification at 3 month stability testing
This product could cause temporary or reversible health problems — stop using it.
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