Why it was recalled
Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: 914227; Exp 06/16
Where it was sold
NY
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0785-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 16, 2015
- FDA report date
- Apr 6, 2016
- Quantity
- 23 cups
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Safecor Health, LLC
Original FDA data
Every field from FDA enforcement report D-0785-2016, exactly as published.
Show all FDA fields
- City
- Woburn
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 72948
- Address
- 317 New Boston St
- Code information
- Lot #: 914227; Exp 06/16
- Postal code
- 01801-6231
- Report date
- Apr 6, 2016
- Product type
- Drugs
- Recall number
- D-0785-2016
- Classification
- Class II
- Recalling firm
- Safecor Health, LLC
- Product quantity
- 23 cups
- Termination date
- Mar 30, 2016
- Reason for recall
- Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- NY
- Recall initiation date
- Jul 16, 2015
- Initial firm notification
- Letter
- Center classification date
- Mar 29, 2016