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| DAN Medical Calls |
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| Emergency | 261 |
| Information | 356 |
| Email | 272 |
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Released Nov. 12, 2003
The FDA has released the following information.
PRODUCT
Oxygen, USP, Compressed, cylinders, sizes-H, E, D, C, ML 6 and M6, Rx. Recall # D-040-4.
CODE
All Lots.
RECALLING FIRM / MANUFACTURER
Classic Medical Inc., St. Clair Shores, Mich., by firm visit. Firm initiated recall is ongoing.
REASON
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).
DISTRIBUTION
Mich.
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