May 2012 FDA Recall Drug by Linde Gas Llc
D-1383-2012 - CGMP Deviations
This Class II drug recall was voluntarily initiated by Linde Gas Llc on May 4, 2012 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Distributed only within Ohio. No Federal Government, foreign or Canadian consignees received product. and the recall is currently terminated.
Recall Number: D-1383-2012
CGMP Deviations: The pressure gages, vacuum gages, and thermometer had surpassed the calibration expiry period, which may have resulted in overfill/underfill of oxygen cylinders.
05-04-2012
06-27-2012
283 cylinders
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.
Linde Gas LLC
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.
Other
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed only within Ohio. No Federal Government, foreign or Canadian consignees received product.
06-11-2013
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
LifeGas OXYGEN COMPRESSED UN1072 USP, Distributed by: Linde
Batch or Lot Expiration Information
Lot# : 117H201
Lot# : 117H202
