Why it was recalled
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Product description
Alprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b) 60 Tabs per bottle, NDC 72189-213-60; Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534.
Lot numbers, UPCs & expiration codes
Lots: a) 03FE2318, Exp. 8/31/24; b) 27FE2315, 28FE2313, 02MA2306, 21SE2201, 16NO2216, 17NO2216, 24FA2314, Exp. 8/31/24; 17FE2203, 12AP2204, 17MA2205, Exp. 3/31/23; 21JU2206, 22JU2220, 12JY2206, Exp. 5/31/23; 10AU2209, Exp. 6/30/23; 14DE2215, Exp. 9/30/24; 05JA2304, 27JA2301, Exp. 11/30/24.
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-0508-2023
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 22, 2023
- FDA report date
- Apr 12, 2023
- Quantity
- 349 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Direct Rx
Original FDA data
Every field from FDA enforcement report D-0508-2023, 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: a) 03FE2318, Exp. 8/31/24; b) 27FE2315, 28FE2313, 02MA2306, 21SE2201, 16NO2216, 17NO2216, 24FA2314, Exp. 8/31/24; 17FE2203, 12AP2204, 17MA2205, Exp. 3/31/23; 21JU2206, 22JU2220, 12JY2206, Exp. 5/31/23; 10AU2209, Exp. 6/30/23; 14DE2215, Exp. 9/30/24; 05JA2304, 27JA2301, Exp. 11/30/24.
- Postal code
- 30534-6828
- Report date
- Apr 12, 2023
- Product type
- Drugs
- Recall number
- D-0508-2023
- Classification
- Class II
- Recalling firm
- Direct Rx
- Product quantity
- 349 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, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b) 60 Tabs per bottle, NDC 72189-213-60; Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Mar 22, 2023
- Initial firm notification
- Letter
- Center classification date
- Apr 6, 2023