QUELICIN Injection recalled over sterility concerns
- Recall date
- June 22, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Advanced Pharma Inc. recalls QUELICIN (Succinylcholine Chloride) Injection, USP 20 mg/mL in a) 5 mL vial (NDC 15082-814-67), b) 7mL vial (NDC 15082-…
- Recall number
- D-0953-2017
- FDA classification
- Class II
- Brand / firm
- Advanced Pharma Inc.
- Sold / distributed
- Nationwide with the United States
Why it was recalled
Lack of Assurance of Sterility
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
QUELICIN (Succinylcholine Chloride) Injection, USP 20 mg/mL in a) 5 mL vial (NDC 15082-814-67), b) 7mL vial (NDC 15082-814-79), c) 10mL vial (NDC 15082-814-61), Repackaged by Advanced Pharm, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404.
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