SENNA Syrup (sennosides) 8.8 mg/ 5 mL unit-dose cups, packaged in 24 cups per carton, Mfg for: AvKARE, TN 38478, NDC 50
Summary
The FDA issued a Class I for SENNA Syrup (sennosides) 8.8 mg/ 5 mL unit-dose cups, packaged in 24 cups per ca by Lohxa, LLC. Reason: Microbial Contamination of Non-Sterile Product.
Details
Source
Drug Recall
External ID
D-0377-2022
Action Date
2022-01-26
Status
Terminated
Category
drug
Product Description
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.
Lot/Code Info: Lot #: AM1115S, Exp. Date 01/2023
Quantity Affected: 87,840 unit dose cups
Reason for Recall
Microbial Contamination of Non-Sterile Product
Distribution
Product was distributed to one wholesale who further distributed the product nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-21
Company
Worcester, MA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 44 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Lohxa, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Lohxa, LLC have FDA actions?
This is the only FDA action we have on record for Lohxa, LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0377-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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