D-1128-2017 Class III Terminated
FDA drug recall D-1128-2017 was initiated by Mckesson Packaging Services on August 28, 2017 and is designated Class III. Reason for recall: Failed moisture limits: Out of specification for moisture content. The recall status is terminated (terminated May 19, 2020). Affected quantity: 3966 unit-dose boxes.
Recall Details
- Product Type
- Drugs
- Report Date
- September 13, 2017
- Initiation Date
- August 28, 2017
- Termination Date
- May 19, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3966 unit-dose boxes
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
Reason for Recall
Failed moisture limits: Out of specification for moisture content.
Distribution Pattern
PA, OH, IL, CO, LA
Code Information
Lot#: 0112313 Exp. 12/2017; 0113376 Exp. 06/2018; 0113645 Exp. 02/2019.