Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Short Fill: Due to an error in the manufacturing process, cylinders in this lot may be empty and contain no medical oxygen.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
Oxygen, Compressed USP, in an aluminum cylinder, Rx only, Airgas USA, LLC, Radnor PA 19087 Distributed by Keene Medical Products, 240 Meridian Road, NH 03766. NDC 11054-009
Compare with the code on your package — it is the most precise check available.
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Oxygen NDC 11054-0009 |
992 mL/L | Gas Cutaneous|respiratory (inhalation) |
Airgas USA, LLC | Rx |
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Labeling: Not Elsewhere Classified; Due to an error in the manufacturing procedure, a cylinder in liquid withdrawal service was not marked Syphon Tube indicating liquid withdrawal and shipped as a gas withdrawal cylinder.
Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples.
Failed Tablet/Capsule Specifications: There is a potential for broken tablets.
Presence of Precipitate; precipitation of drug product
Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below specification in some tablets
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