November 12, 2003
Classic Medical Has Recalled Oxygen
The FDA has released the following information.
Oxygen, USP, Compressed, cylinders, sizes-H, E, D, C, ML 6 and M6, Rx.
Recall # D-040-4.
Classic Medical Inc., St. Clair Shores, MI, by firm visit. Firm initiated
recall is ongoing.
Good Manufacturing Practice Deviations (GMPs); including but not limited to,
failure to perform purity analysis.
VOLUME OF PRODUCT IN COMMERCE
Pending determination (estimate 50 cylinders).