Drug product
Good Neighbor Pharmacy PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 0.4% / Propylene Glycol 0.3%), 15 ml bottle, Distributed by AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087, NDC 46122-199-05, ALSO labeled as Premier Value Brand PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 0.4% / Propylene Glycol 0.3%), 15 ml bottle, Distributed by Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 68016-0404-00.
D-0835-2016
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 73642
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10,060 bottles (Good Neighbor Pharmacy: 6,731 bottles/Premier Value Brand: 3,323 bottles)
- Official record key
drug-enforcement:D-0835-2016
Official wording
Reason: Presence of Particulate Matter
Code information: Good Neighbor Pharmacy Batch Number 4H76A; Exp 07/16 Premier Value Batch Number 4H76B; Exp 07/16
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter