Why it was recalled
Microbial Contamination of Non-Sterile Product
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 numbers, UPCs & expiration codes
Lot #: AM1115S, Exp. Date 01/2023
Where it was sold
Product was distributed to one wholesale who further distributed the product nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0377-2022
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 21, 2021
- FDA report date
- Jan 26, 2022
- Quantity
- 87,840 unit dose cups
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lohxa, LLC
Original FDA data
Every field from FDA enforcement report D-0377-2022, exactly as published.
Show all FDA fields
- City
- Worcester
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 89272
- Address
- 600 Main St Ste 110
- Code information
- Lot #: AM1115S, Exp. Date 01/2023
- Postal code
- 01608-2061
- Report date
- Jan 26, 2022
- Product type
- Drugs
- Recall number
- D-0377-2022
- Classification
- Class I
- Recalling firm
- Lohxa, LLC
- Product quantity
- 87,840 unit dose cups
- Termination date
- Nov 15, 2022
- Reason for recall
- Microbial Contamination of Non-Sterile Product
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Product was distributed to one wholesale who further distributed the product nationwide in the USA
- Recall initiation date
- Dec 21, 2021
- Initial firm notification
- Letter
- Center classification date
- Jan 18, 2022