Phenobarbital/Hyoscyamine/ Atropine/Scopolamine 16.2/0.1037/0.0194/0.0065 mg DONNATAL ELIXIR, 5 ml Cup grape, Alcohol 23.8%, Rx Only, MFG: Concordia, PKG BY: SAFECOR HEALTH, WOBURN, MA, C5921242304.

FDA recall notice · announced April 6, 2016 · Safecor Health

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

The product

Phenobarbital/Hyoscyamine/ Atropine/Scopolamine 16.2/0.1037/0.0194/0.0065 mg DONNATAL ELIXIR, 5 ml Cup grape, Alcohol 23.8%, Rx Only, MFG: Concordia, PKG BY: SAFECOR HEALTH, WOBURN, MA, C5921242304.

Reason for recall

Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml.

Notes

Distribution: NY
Lot/code information: Lot #: 914227; Exp 06/16
Quantity: 23 cups
Status: Terminated
Products in this recall event:
- Phenobarbital/Hyoscyamine/ Atropine/Scopolamine 16.2/0.1037/0.0194/0.0065 mg DONNATAL ELIXIR, 5 ml Cup grape, Alcohol 23.8%, Rx Only, MFG: Concordia, PKG BY: SAFECOR HEALTH, WOBURN, MA, C5921242304. (D-0785-2016)

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