Bismuth Subsalicylate Oral Suspension 262mg/15mL, unit dose cups, OTC, Rpkg. By.: Lohxa Worcester, MA, NDC 70166-059-01

FDA recall notice · announced April 17, 2019 · Lohxa

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Bismuth Subsalicylate Oral Suspension 262mg/15mL, unit dose cups, OTC, Rpkg. By.: Lohxa Worcester, MA, NDC 70166-059-01

Reason for recall

Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.

Notes

Distribution: MA, NY and WY
Lot/code information: Lot#: M030042P, Exp. 01/2020
Quantity: 5 boxes - 250 unit dose cups.
Status: Terminated
Products in this recall event:
- 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)
- Bismuth Subsalicylate Oral Suspension 262mg/15mL, unit dose cups, OTC, Rpkg. By.: Lohxa Worcester, MA, NDC 70166-059-01 (D-1130-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.