Drug product
Bismuth Subsalicylate Oral Suspension 262mg/15mL, unit dose cups, OTC, Rpkg. By.: Lohxa Worcester, MA, NDC 70166-059-01
D-1130-2019
Product summary
- Firm
- Lohxa LLC
- Event
- Event 82538
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 boxes - 250 unit dose cups.
- Official record key
drug-enforcement:D-1130-2019
Official wording
Reason: Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.
Code information: Lot#: M030042P, Exp. 01/2020
Distribution pattern: MA, NY and WY
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing