Drug product
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.
D-0055-2018
Product summary
- Firm
- AVKARE Inc.
- Event
- Event 78240
- Status
- Terminated
- Classification
- Class II
- Quantity
- 274 cartons
- Official record key
drug-enforcement:D-0055-2018
Official wording
Reason: Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.
Code information: Lot: 18103 Exp. 11/18
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications