D-0055-2018 Class II Terminated
FDA drug recall D-0055-2018 was initiated by AVKARE Inc. on October 6, 2017 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid. The recall status is terminated (terminated March 11, 2019). Affected quantity: 274 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- November 8, 2017
- Initiation Date
- October 6, 2017
- Termination Date
- March 11, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 274 cartons
Product Description
Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton, unit dose blister UPC 5026828311), Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-283-15.
Reason for Recall
Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.
Distribution Pattern
Nationwide in the USA
Code Information
Lot: 18103 Exp. 11/18