Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
cGMP deviations: Temperature abuse
Glucagen (glucagon) for injection, packaged in a 10-count box, (10 vials each containing 1 mg per vial), Rx only, MFG: Boehringer Mannheim, NDC 0597-0053-45
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Reason cGMP deviations: Temperature abuse
Reason cGMP deviations: Temperature abuse
Reason SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of full drug effect upon…
Reason Defective delivery system: detached needles on the syringe in the kit.
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