November 2015 FDA Recall Drug by Aga Gas Inc
D-0779-2016 - cGMP Deviations; trailer may not have met GMP requirements prior to filling
This Class II drug recall was voluntarily initiated by Aga Gas Inc on November 29, 2015 for the product Drug. The FDA reported the reason for recall as cgmp deviations; trailer may not have met gmp requirements prior to filling. The product was distributed in Product was delivered to Ohio and the recall is currently terminated.
Recall Number: D-0779-2016
cGMP Deviations; trailer may not have met GMP requirements prior to filling
11-29-2015
03-30-2016
1,500 gallons
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
AGA Gas Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was delivered to Ohio
12-13-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Oxygen, USP, 99.0%, Bulk Cryogenic Liquid, Rx, Airgas Merchant Gases, LLC, Independence, OH --- NDC 33237-001-01
Batch or Lot Expiration Information
Lot# 7931-O-V32-5330-5-1062
