Recalls / Class II
Class IID-0835-2016
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.
- Affected lot / code info
- Good Neighbor Pharmacy Batch Number 4H76A; Exp 07/16 Premier Value Batch Number 4H76B; Exp 07/16
Why it was recalled
Presence of Particulate Matter
Recalling firm
- Firm
- Akorn, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W Field Ct Ste 300, Lake Forest, Illinois 60045-4862
Distribution
- Quantity
- 10,060 bottles (Good Neighbor Pharmacy: 6,731 bottles/Premier Value Brand: 3,323 bottles)
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-04-07
- FDA classified
- 2016-05-04
- Posted by FDA
- 2016-05-11
- Terminated
- 2016-09-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0835-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.