FDA Enforcement
Class II
Terminated
GREER 2 ML Sterile Empty Vials 2-13 vial 25 ea - Silver Cap
Recall: Z-2785-2016
·
Reported September 21, 2016
Enforcement
- Recall Number
- Z-2785-2016
- Event ID
- 74851
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Allergy Laboratories, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- September 21, 2016
- Initiation Date
- February 3, 2015
- Classification Date
- September 12, 2016
- Termination Date
- March 13, 2017
- Address
- 1005 SW 2nd St, N/A, Oklahoma City, OK, 73109-1006, United States
Description
GREER 2 ML Sterile Empty Vials 2-13 vial 25 ea - Silver Cap
Reason
Potential for glass particles within the vials
Code Info
SEV2120414, SEV2120514
Distribution
US Distribution to the state of : NC
Quantity
81,625 vials (3,265 packs)