Why it was recalled
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Product description
Alprazolam C-IV, 2 mg, 60 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-121-60.
Lot numbers, UPCs & expiration codes
Lots: 03FE2319 Exp. 2/28/25, 13MY2217 Exp. 5/31/23
Where it was sold
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-0509-2023
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 22, 2023
- FDA report date
- Apr 12, 2023
- Quantity
- 9 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Direct Rx
Original FDA data
Every field from FDA enforcement report D-0509-2023, exactly as published.
Show all FDA fields
- City
- Dawsonville
- State
- GA
- Status
- Ongoing
- Country
- United States
- Event ID
- 92054
- Address
- 94 Worldwide Dr
- Code information
- Lots: 03FE2319 Exp. 2/28/25, 13MY2217 Exp. 5/31/23
- Postal code
- 30534-6828
- Report date
- Apr 12, 2023
- Product type
- Drugs
- Recall number
- D-0509-2023
- Classification
- Class II
- Recalling firm
- Direct Rx
- Product quantity
- 9 bottles
- Reason for recall
- CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Alprazolam C-IV, 2 mg, 60 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-121-60.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Mar 22, 2023
- Initial firm notification
- Letter
- Center classification date
- Apr 6, 2023