Loxapine Capsules USP, 5mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 00591-0369-01.

FDA recall notice · announced July 11, 2012 · Watson Laboratories

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

Reason for recall

Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.

Notes

Distribution: Nationwide.
Lot/code information: Lot 108094A
Quantity: 8254 bottles
Status: Terminated
Products in this recall event:
- Loxapine Capsules USP, 50mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0372-01 (D-1402-2012)
- Loxapine Capsules USP, 10mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 Rx only. NDC # 0591-0370-01 (D-1400-2012)
- Loxapine Capsules USP, 25mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0371-01 (D-1401-2012)
- Loxitane Capsules, Loxapine Succinate Capsules, 10mg base, 100 count bottle, Rx only, Watson Laboratories Inc., Corona, CA 92880 NDC # 52544-495-01 (D-1403-2012)
- Loxapine Capsules USP, 5mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 00591-0369-01. (D-1399-2012)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.