Why it was recalled
Failed moisture limits: Out of specification for moisture content.
Product description
Propafenone Hydrochloride tablets, 150 mg, packaged in 10 x 10 unit dose cards (100-count box), Rx only, Manufactured By: Watson Pharmaceuticals 311 Bonnie Circle Corona, CA 92880, NDC 63739-509-10
Lot numbers, UPCs & expiration codes
Lot#: 0112313 Exp. 12/2017; 0113376 Exp. 06/2018; 0113645 Exp. 02/2019.
Where it was sold
PA, OH, IL, CO, LA
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-1128-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 28, 2017
- FDA report date
- Sep 13, 2017
- Quantity
- 3966 unit-dose boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mckesson Packaging Services
Original FDA data
Every field from FDA enforcement report D-1128-2017, exactly as published.
Show all FDA fields
- City
- Concord
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 78020
- Address
- 7101 Weddington Rd NW
- Code information
- Lot#: 0112313 Exp. 12/2017; 0113376 Exp. 06/2018; 0113645 Exp. 02/2019.
- Postal code
- 28027-3412
- Report date
- Sep 13, 2017
- Product type
- Drugs
- Recall number
- D-1128-2017
- Classification
- Class III
- Recalling firm
- Mckesson Packaging Services
- Product quantity
- 3966 unit-dose boxes
- Termination date
- May 19, 2020
- Reason for recall
- Failed moisture limits: Out of specification for moisture content.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Propafenone Hydrochloride tablets, 150 mg, packaged in 10 x 10 unit dose cards (100-count box), Rx only, Manufactured By: Watson Pharmaceuticals 311 Bonnie Circle Corona, CA 92880, NDC 63739-509-10
- Distribution pattern
- PA, OH, IL, CO, LA
- Recall initiation date
- Aug 28, 2017
- Initial firm notification
- Letter
- Center classification date
- Sep 6, 2017