SENNA Syrup 8 recalled over sterility concerns
- Recall date
- December 21, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Lohxa, LLC recalls SENNA Syrup (sennosides) 8.8 mg/ 5 mL unit-dose cups, packaged in 24 cups per carton, Mfg for: AvKARE, TN 38478, NDC 50…
- Recall number
- D-0377-2022
- FDA classification
- Class I
- Brand / firm
- Lohxa, LLC
- Sold / distributed
- Product was distributed to one wholesale who further distributed the product nationwide in the USA
Why it was recalled
Microbial Contamination of Non-Sterile Product
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
SENNA Syrup (sennosides) 8.8 mg/ 5 mL unit-dose cups, packaged in 24 cups per carton, Mfg for: AvKARE, TN 38478, NDC 50262-731-24.
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