Drug product
Phenobarbital Oral Solution, USP 20 mg/5mL, unit dose cup, Rx Only, Rpkg. By.Lohxa Worcester, MA 01608 NDC 70166-536-02
D-1131-2019
Product summary
- Firm
- Lohxa LLC
- Event
- Event 82538
- Status
- Terminated
- Classification
- Class II
- Quantity
- 46 boxes - 1380 unit dose cups
- Official record key
drug-enforcement:D-1131-2019
Official wording
Reason: Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.
Code information: Lot# M12031, Exp. 12/2019; T01241 Exp. 02/2020
Distribution pattern: MA, NY and WY
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing