Class III · Low risk
Candesartan Cilexetil Tablets
Failed Impurities/Degradation Specifications; 9 month stability timepoint
Air Compressed
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specification; out of specification results for carbon dioxide
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
AIR COMPRESSED, Medical Air, USP, Rx Only. Matheson Tri-Gas, Inc., 150 Allen Road, Basking Ridge, NJ 07920. Available in A) E or 22 cu ft cylinder, NDC: 55037-302-09; B) 40 cu ft cylinder, NDC: 55037-302-10; C) 200 cu ft cylinder, NDC: 55037-302-15; D) 220 cu ft cylinder, NDC: 55037-302-16; E) 300 cu ft cylinder, NDC: 55037-302-18, 55037-302-19, 55037-302-20.
Affected NDCs
55037-0302-09
55037-0302-10
55037-0302-15
55037-0302-16
55037-0302-18
55037-0302-19
55037-0302-20
Compare with the code on your package — it is the most precise check available.
Product details
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 |
|---|---|---|---|---|
| Air NDC 55037-0302 |
1000 mL/L | Gas Respiratory (inhalation) |
Matheson Tri-Gas, Inc. | Rx |
- Recalling firm
- Matheson, Inc.
- Origin
- MN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0423-2015 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other impurity / degradation recalls from 2015
All impurity / degradation recalls
Class III · Low risk
Ranitidine Syrup
Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing.
Class III · Low risk
Quinapril Tablets USP 5 mg
Failed Impurities/Degradation Specifications; Impurity A
Class III · Low risk
Meclizine Hydrochloride Tablets
Failed Impurities/Degradation Specifications: Out of specification for impurities.
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