Why it was recalled
Failed Impurities/Degradation Specifications: Out-of-specification result for an unknown impurity.
Product description
Alprazolam Tablets, USP, 0.25 mg, 100-count Unit Dose tablets per carton, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa 403 722 INDIA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-5858-61.
Lot numbers, UPCs & expiration codes
Lot 1274C151A, Exp 10/17
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-0013-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 26, 2017
- FDA report date
- Oct 25, 2017
- Quantity
- 3,935 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Harvard Drug Group
Original FDA data
Every field from FDA enforcement report D-0013-2018, exactly as published.
Show all FDA fields
- City
- Livonia
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 78162
- Address
- 17177 N Laurel Park Dr Ste 233
- Code information
- Lot 1274C151A, Exp 10/17
- Postal code
- 48152-3951
- Report date
- Oct 25, 2017
- Product type
- Drugs
- Recall number
- D-0013-2018
- Classification
- Class II
- Recalling firm
- The Harvard Drug Group
- Product quantity
- 3,935 cartons
- Termination date
- Apr 29, 2020
- Reason for recall
- Failed Impurities/Degradation Specifications: Out-of-specification result for an unknown impurity.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Alprazolam Tablets, USP, 0.25 mg, 100-count Unit Dose tablets per carton, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa 403 722 INDIA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-5858-61.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Sep 26, 2017
- Initial firm notification
- Letter
- Center classification date
- Oct 19, 2017