D-0779-2016 Class II Terminated

Recalled by AGA Gas Inc — Independence, OH

FDA drug recall D-0779-2016 was initiated by AGA Gas Inc on November 29, 2015 and is designated Class II. Reason for recall: cGMP Deviations; trailer may not have met GMP requirements prior to filling The recall status is terminated (terminated December 13, 2017). Affected quantity: 1,500 gallons.

Recall Details

Product Type
Drugs
Report Date
March 30, 2016
Initiation Date
November 29, 2015
Termination Date
December 13, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,500 gallons

Product Description

Oxygen, USP, 99.0%, Bulk Cryogenic Liquid, Rx, Airgas Merchant Gases, LLC, Independence, OH --- NDC 33237-001-01

Reason for Recall

cGMP Deviations; trailer may not have met GMP requirements prior to filling

Distribution Pattern

Product was delivered to Ohio

Code Information

Lot# 7931-O-V32-5330-5-1062