Class III · Low risk
Pentasa (mesalamine)
Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
Kalbitor (ecallantide)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of Particulate Matter: Glass
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, Dynax Corp., Burlington, MA. NDC47783-101-01
- Recalling firm
- Shire
- NDC code
- 47783-101-01
- Origin
- MA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0625-2017 · FDA notice
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.
Other recalls by Shire
All 2017 recalls
Class III · Low risk
Vyvanse (lisdexamfetamine dimesylate)
Presence of Foreign Tablets/Capsules
Other particulate / foreign matter recalls from 2017
All particulate / foreign matter recalls
Class III · Low risk
Simvastatin Tablets
Presence of foreign substance: metallic razor blade was found in one bottle.
Class II · Moderate risk
Fosphenytoin Sodium Injection
Presence of particulate matter
Class II · Moderate risk
0.25% Acetic Acid Irrigation USP
Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap
Class III · Low risk
Auryxia (ferric citrate)
Presence of Foreign Substance: Reports have been received of damaged StripPax packets containing silica gel desiccant potentially allowing the silica gel granules to make contact with Auryxia tablets in the bottle.
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