Recalls / Class II
Class IID-0785-2016
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.
- Affected lot / code info
- Lot #: 914227; Exp 06/16
Why it was recalled
Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml.
Recalling firm
- Firm
- Safecor Health, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 317 New Boston St, N/A, Woburn, Massachusetts 01801-6231
Distribution
- Quantity
- 23 cups
- Distribution pattern
- NY
Timeline
- Recall initiated
- 2015-07-16
- FDA classified
- 2016-03-29
- Posted by FDA
- 2016-04-06
- Terminated
- 2016-03-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0785-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.