Why it was recalled
Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.
Product description
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: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454; NDC 0093-4125-73.
Lot numbers, UPCs & expiration codes
Lot # 35433115A, Exp 01/18
Where it was sold
Nationwide in the USA and Puerto Rico.
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-0108-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 28, 2017
- FDA report date
- Dec 20, 2017
- Quantity
- 42,384 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0108-2018, exactly as published.
Show all FDA fields
- City
- North Wales
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 78641
- Address
- 1090 Horsham Rd
- Code information
- Lot # 35433115A, Exp 01/18
- Postal code
- 19454-1505
- Report date
- Dec 20, 2017
- Product type
- Drugs
- Recall number
- D-0108-2018
- Classification
- Class III
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 42,384 bottles
- Termination date
- Jul 3, 2018
- Reason for recall
- Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454; NDC 0093-4125-73.
- Distribution pattern
- Nationwide in the USA and Puerto Rico.
- Recall initiation date
- Nov 28, 2017
- Initial firm notification
- Letter
- Center classification date
- Dec 13, 2017