Why it was recalled
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Product description
Loxapine Capsules USP, 10mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 Rx only. NDC # 0591-0370-01
Lot numbers, UPCs & expiration codes
Lot #s: 107886A, 107887A, 112874A, 144274A, 196483A, 201146A, 217265A, 260747B, 283308A, 313279A, 313279B, 327892A, 327893A, 327894A, 387239A, 387240A, 427259A, 427260A, 456251A.
Where it was sold
Nationwide.
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-1400-2012
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 17, 2012
- FDA report date
- Jul 11, 2012
- Quantity
- 106,323 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Watson Laboratories Inc
Original FDA data
Every field from FDA enforcement report D-1400-2012, exactly as published.
Show all FDA fields
- City
- Corona
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 62383
- Address
- 311 Bonnie Cir
- Code information
- Lot #s: 107886A, 107887A, 112874A, 144274A, 196483A, 201146A, 217265A, 260747B, 283308A, 313279A, 313279B, 327892A, 327893A, 327894A, 387239A, 387240A, 427259A, 427260A, 456251A.
- Postal code
- 92880-2882
- Report date
- Jul 11, 2012
- Product type
- Drugs
- Recall number
- D-1400-2012
- Classification
- Class III
- Recalling firm
- Watson Laboratories Inc
- Product quantity
- 106,323 bottles
- Termination date
- Mar 18, 2013
- Reason for recall
- Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Loxapine Capsules USP, 10mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 Rx only. NDC # 0591-0370-01
- Distribution pattern
- Nationwide.
- Recall initiation date
- Apr 17, 2012
- Initial firm notification
- Letter
- Center classification date
- Jun 29, 2012