D-1131-2019 Class II Terminated
FDA drug recall D-1131-2019 was initiated by Lohxa LLC on March 25, 2019 and is designated Class II. Reason for recall: Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date. The recall status is terminated (terminated June 20, 2023). Affected quantity: 46 boxes - 1380 unit dose cups.
Recall Details
- Product Type
- Drugs
- Report Date
- April 17, 2019
- Initiation Date
- March 25, 2019
- Termination Date
- June 20, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 46 boxes - 1380 unit dose cups
Product Description
Phenobarbital Oral Solution, USP 20 mg/5mL, unit dose cup, Rx Only, Rpkg. By.Lohxa Worcester, MA 01608 NDC 70166-536-02
Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.
Distribution Pattern
MA, NY and WY
Code Information
Lot# M12031, Exp. 12/2019; T01241 Exp. 02/2020