FDA Recall D-0377-2022
Lohxa, LLC · Worcester, MA
Class I — life-threatening Terminated 329 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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.
Reason for recall
Microbial Contamination of Non-Sterile Product
Recall record
- Recall number
D-0377-2022- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Product was distributed to one wholesale who further distributed the product nationwide in the USA
- Recall initiated
- 2021-12-21
- Classified by FDA Center
- 2022-01-18
- FDA published
- 2022-01-26
- Terminated
- 2022-11-15
- Recalling firm
- Lohxa, LLC
- Firm location
- Worcester, MA