Recalls / Class III
Class IIID-1128-2017
Product
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
- Affected lot / code info
- Lot#: 0112313 Exp. 12/2017; 0113376 Exp. 06/2018; 0113645 Exp. 02/2019.
Why it was recalled
Failed moisture limits: Out of specification for moisture content.
Recalling firm
- Firm
- Mckesson Packaging Services
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7101 Weddington Rd NW, N/A, Concord, North Carolina 28027-3412
Distribution
- Quantity
- 3966 unit-dose boxes
- Distribution pattern
- PA, OH, IL, CO, LA
Timeline
- Recall initiated
- 2017-08-28
- FDA classified
- 2017-09-06
- Posted by FDA
- 2017-09-13
- Terminated
- 2020-05-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1128-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.