Drug product
Preferred Pharmaceuticals, Inc. The Physician's Solution., Lansoprazole Delayed-Release Capsules, 15mg, Generic for Prevacid, 90-Count Bottle, Manufacturer: Dr Reddy's Laboratories Limited, NDC 68788-6390-09
D-0769-2022
Product summary
- Event
- Event 89950
- Status
- Terminated
- Classification
- Class II
- Quantity
- 791 bottles of 90 - Count
- Official record key
drug-enforcement:D-0769-2022
Official wording
Reason: Out of specification results observed in dissolution during long term stability testing.
Code information: Lots: H0221R, D3021T, D2221J, D1321X, Exp.12/31/2023.
Distribution pattern: Nationwide in the USA and CA.
Derived failure modes
-
Potency or specification failure
Out of specification