Recalls / Class III
Class IIID-0108-2018
Product
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.
- Brand name
- Penicillin V Potassium
- Generic name
- Penicillin V Potassium
- Active ingredient
- Penicillin V Potassium
- Route
- Oral
- NDCs
- 0093-1172, 0093-1174, 0093-4125, 0093-4127
- FDA application
- ANDA060711
- Affected lot / code info
- Lot # 35433115A, Exp 01/18
Why it was recalled
Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1090 Horsham Rd, N/A, North Wales, Pennsylvania 19454-1505
Distribution
- Quantity
- 42,384 bottles
- Distribution pattern
- Nationwide in the USA and Puerto Rico.
Timeline
- Recall initiated
- 2017-11-28
- FDA classified
- 2017-12-13
- Posted by FDA
- 2017-12-20
- Terminated
- 2018-07-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0108-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.