CLASS II Drug recall · Reported 6 Apr 2016 · FDA Enforcement Report
Phenobarbital/Hyoscyamine/ Atropine/Scopolamine recalled
Safecor Health is recalling Phenobarbital/Hyoscyamine/ Atropine/Scopolamine 16.2/0.1037/0.0194/0.0065 mg Donnatal, distributed in New York. The recall was initiated on 16 Jul 2015 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0785-2016
- FDA event ID
- 72948
- Recalling firm
- Safecor Health, Woburn, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Jul 2015
- FDA classified
- 29 Mar 2016
- Reported
- 6 Apr 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 16 Jul 2015 | Recall initiated by company | |
| 29 Mar 2016 | Classified by FDA | +257 days |
| 6 Apr 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml.
Product as listed by the FDA
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.
Where it was distributed
NY
Questions about this recall
Why was it recalled?
Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml.
Which lots are affected?
Lot #: 914227; Exp 06/16
Where was it sold?
NY
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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