Loxapine Capsules recall: CGMP Deviations
Loxapine Capsules, USP 50 mg, Rx Only, 100-count bottles, NDC 0378-7050-01
Why was Loxapine Capsules recalled?
CGMP Deviations
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
NDC 0378-7050-01 Lot Numbers: 3079386, Exp. 10/31/18 3079387, Exp. 10/31/18 3079388, Exp. 10/31/18 3083762, Exp. 3/31/19 3083763, Exp. 3/31/19 3083764, Exp. 3/31/19 3083765, Exp. 3/31/19 3083766, Exp. 3/31/19 3083767, Exp. 3/31/19
- Product
- Loxapine Capsules, USP 50 mg, Rx Only, 100-count bottles, NDC 0378-7050-01
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Quantity
- 11,650 bottles
- Distribution
- Product was distributed throughout the United States, including Puerto Rico.
- Recall date
- May 30, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)