Why it was recalled
GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
Product description
Loxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC 51079-902-20
Lot numbers, UPCs & expiration codes
Lot #: 3090454, Exp. 03/2019
Where it was sold
Nationwide in the U.S.
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-0822-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 1, 2018
- FDA report date
- May 30, 2018
- Quantity
- 1,065 blister cards of 100 capsules each
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Original FDA data
Every field from FDA enforcement report D-0822-2018, exactly as published.
Show all FDA fields
- City
- Rockford
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 79977
- Address
- 1718 Northrock Ct
- Code information
- Lot #: 3090454, Exp. 03/2019
- Postal code
- 61103-1201
- Report date
- May 30, 2018
- Product type
- Drugs
- Recall number
- D-0822-2018
- Classification
- Class II
- Recalling firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Product quantity
- 1,065 blister cards of 100 capsules each
- Termination date
- Mar 10, 2021
- Reason for recall
- GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Loxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC 51079-902-20
- Distribution pattern
- Nationwide in the U.S.
- Recall initiation date
- May 1, 2018
- Initial firm notification
- Letter
- Center classification date
- May 22, 2018