Drug product
DEXAMETHASONE ELIXIR, USP, 0.5 mg/5 mL, 8 fl.oz., Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL, NDC 0603-1147-56
D-0438-2017
Product summary
- Event
- Event 76272
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2568 bottles
- Official record key
drug-enforcement:D-0438-2017
Official wording
Reason: Failed Impurities/ Degradation Specifications
Code information: Lot # 0000007104; Exp 05/17
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Failed Impurities/ Degradation Specifications