Reported Dec 20, 2017 · Terminated
Penicillin V Potassium for Oral Solution, USP, 125 mg (200,000 U) per 5 mL, 100 mL (when mixed) bottle, Rx only,…
Teva Pharmaceuticals USA
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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: Teva Pharmaceuticals USA · 1090 Horsham Rd · North Wales, PA · 19454-1505
Is this the product you have?
Penicillin V Potassium for Oral Solution, USP, 125 mg (200,000 U) per 5 mL, 100 mL (when mixed) bottle, Rx only, Manufactured In Canada By
3 of 3 products
| # | Product as published |
|---|---|
| 1 | Teva Canada Limited, Toronto, Canada M1B 2K9 |
| 2 | Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 |
| 3 | NDC 0093-4125-73. |
- Lot codes and dates
Lot # 35433115AExp 01/18
- Amount recalled
- 42,384 bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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