Why it was recalled
Labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as an active ingredient on the side panel instead of Scopolamine Hydrobromide.
Product description
Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) tablets, 100-count bottle, Rx only, Manufactured for Concordia Pharmaceuticals, Inc., St. Michael, Barbados BB11005, Manufactured by IriSys, LLC San Diego, CA 92121, Repackaged by: RxPak, Div. of McKesson, Memphis, TN 38141, NDC 59212-425-10
Lot numbers, UPCs & expiration codes
Lot #: 107934 Exp 9/16, 108060 Exp 5/16
Where it was sold
Nationwide
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-0053-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 13, 2015
- FDA report date
- Oct 28, 2015
- Quantity
- 2530 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Rx PAK
Original FDA data
Every field from FDA enforcement report D-0053-2016, exactly as published.
Show all FDA fields
- City
- Memphis
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 72457
- Address
- 4971 Southridge Blvd Ste 111-115
- Code information
- Lot #: 107934 Exp 9/16, 108060 Exp 5/16
- Postal code
- 38141-8300
- Report date
- Oct 28, 2015
- Product type
- Drugs
- Recall number
- D-0053-2016
- Classification
- Class III
- Recalling firm
- Rx PAK
- Product quantity
- 2530 bottles
- Termination date
- Jun 30, 2016
- Reason for recall
- Labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as an active ingredient on the side panel instead of Scopolamine Hydrobromide.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) tablets, 100-count bottle, Rx only, Manufactured for Concordia Pharmaceuticals, Inc., St. Michael, Barbados BB11005, Manufactured by IriSys, LLC San Diego, CA 92121, Repackaged by: RxPak, Div. of McKesson, Memphis, TN 38141, NDC 59212-425-10
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 13, 2015
- Initial firm notification
- Center classification date
- Oct 21, 2015