D-0438-2017 Class III Terminated
FDA drug recall D-0438-2017 was initiated by Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals on January 16, 2017 and is designated Class III. Reason for recall: Failed Impurities/ Degradation Specifications The recall status is terminated (terminated September 17, 2017). Affected quantity: 2568 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 1, 2017
- Initiation Date
- January 16, 2017
- Termination Date
- September 17, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2568 bottles
Product Description
DEXAMETHASONE ELIXIR, USP, 0.5 mg/5 mL, 8 fl.oz., Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL, NDC 0603-1147-56
Reason for Recall
Failed Impurities/ Degradation Specifications
Distribution Pattern
Nationwide
Code Information
Lot # 0000007104; Exp 05/17