Why it was recalled
CGMP deviations
Product description
Alprazolam Tablets, USP 1mg, Generic for Xanax, Pkg Size: a) 30 tablets per bottle, NDC: 68788-6381-03, b) 60 tablets per bottle, NDC: 68788-6381-06, c) 90 tablets per bottle, NDC: 68788-6381-09, Mfg: Par Pharmaceutical.
Lot numbers, UPCs & expiration codes
Lot #s: a) G2919M, I0619O, F1419J; b) H3019Q; c) F1219N, F1919D, H0219D, I0519R, J0319G, Exp. 03/31/2022.
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-0642-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 22, 2022
- FDA report date
- Mar 9, 2022
- Quantity
- 276 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Preferred Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0642-2022, exactly as published.
Show all FDA fields
- City
- Anaheim
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 89656
- Address
- 1250 N Lakeview Ave Ste O
- Code information
- Lot #s: a) G2919M, I0619O, F1419J; b) H3019Q; c) F1219N, F1919D, H0219D, I0519R, J0319G, Exp. 03/31/2022.
- Postal code
- 92807-1801
- Report date
- Mar 9, 2022
- Product type
- Drugs
- Recall number
- D-0642-2022
- Classification
- Class II
- Recalling firm
- Preferred Pharmaceuticals, Inc.
- Product quantity
- 276 bottles
- Termination date
- May 5, 2023
- Reason for recall
- CGMP deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Alprazolam Tablets, USP 1mg, Generic for Xanax, Pkg Size: a) 30 tablets per bottle, NDC: 68788-6381-03, b) 60 tablets per bottle, NDC: 68788-6381-06, c) 90 tablets per bottle, NDC: 68788-6381-09, Mfg: Par Pharmaceutical.
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Feb 22, 2022
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Mar 1, 2022