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
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
cGMP Deviations; trailer may not have met GMP requirements prior to filling
Oxygen, USP, 99.0%, Bulk Cryogenic Liquid, Rx, Airgas Merchant Gases, LLC, Independence, OH --- NDC 33237-001-01
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason cGMP Deviations
Reason cGMP deviations
Reason CGMP Deviations
Reason GMP Deviations: The firm does not include an SOP for testing for out of specifications.
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…
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