Class II · Moderate risk Terminated
Oxygen, Compressed USP, UN 1072, packaged in cylinders labeled as Size: a) C; b) D; c) E; d) H; e) M; f) M6, Rx only, Family…
Reason cGMP Deviations
Is Oxygen recalled?
11 FDA recalls mention Oxygen. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Oxygen.
Class II · Moderate risk Terminated
Oxygen, Compressed, USP UN 1072, packaged in cylinders labeled as: a) M6 Medical Gas Cylinder, b) C Medical Gas Cylinder; c) D…
Reason cGMP deviations
Class II · Moderate risk Terminated
Oxygen, Refrigerated Liquid USP, Rx only, cylinder, a) Roberts Home Medical, Inc. Rockville MD 20855, b) Roberts Home Medical…
Reason CGMP Deviations
Class II · Moderate risk Terminated
Oxygen Refrigerated Liquid USP UN 1073, Rx only, At Home Medical 200 American Road, Morris Plains, NJ 07950,973-538-0485.
Reason GMP Deviations: The firm does not include an SOP for testing for out of specifications.
Class II · Moderate risk Terminated
Oxygen Nasal Wash (purified water, xylitol, stabilized oxygen, sodium chloride) solution, .75 oz (22mL) bottle, Distributed by…
Reason Marketed Without An Approved NDA/ANDA: product is an unapproved drug due to nasal decongestant claims as well as not complying with the nasal…
Class III · Low risk Terminated
Oxygen, Compressed USP (Gaseous, Medical Oxygen, Aluminum Cylinders), Packaged in a) M6-Tanks, b) D-Tanks, and c) E-Tanks, Rx…
Reason CGMP Deviations: Cylinders filled using out of date gauges.
Class II · Moderate risk Terminated
Oxygen, USP, 99.0%, Bulk Cryogenic Liquid, Rx, Airgas Merchant Gases, LLC, Independence, OH --- NDC 33237-001-01
Reason cGMP Deviations; trailer may not have met GMP requirements prior to filling
Class II · Moderate risk Terminated
Oxygen, Compressed USP, in an aluminum cylinder, Rx only, Airgas USA, LLC, Radnor PA 19087 Distributed by Keene Medical Products…
Reason Short Fill: Due to an error in the manufacturing process, cylinders in this lot may be empty and contain no medical oxygen.
Class II · Moderate risk Terminated
Oxygen, Compressed USP UN1072 Medical Gas supplied in a) 682 litres and b)165 litres cylinders, Rx only, Oklahoma Respiratory…
Reason Failed impurities/degradation specifications: Purity readings for oxygen were out of specification.
Class II · Moderate risk Terminated
OXYGEN, COMPRESSED USP MEDICAL GAS in the following containers: E Cylinder 680L, D Cylinder 425L, and M6 Cylinder 165L, Rx only…
Reason CGMP Deviations; no identity or purity testing on incoming oxygen gas, and lack of documentation
Class II · Moderate risk Terminated
LifeGas OXYGEN COMPRESSED UN1072 USP, Distributed by: Linde
Reason CGMP Deviations: The pressure gages, vacuum gages, and thermometer had surpassed the calibration expiry period, which may have resulted in…
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