Drug product
Penicillin V Potassium Tablets, USP 500 mg (800,000 units) 1000 count bottles, Rx Only, Distributed by: Citron Pharma LLC, East Brunswick, NJ --- NDC 57237-041-99
D-0652-2017
Product summary
- Event
- Event 76738
- Status
- Terminated
- Classification
- Class III
- Quantity
- 420 bottles
- Official record key
drug-enforcement:D-0652-2017
Official wording
Reason: Presence of Foreign Tablet/Capsule; Amoxicillin 500 mg was found in bottles of Penicillin V potassium 500 mg
Code information: Batch Numbers: PE5015069-A, exp 11/2018
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablet