Fexofenadine Hydrochloride Tablets recall: Impurity Out of Spec
Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 NDC 0904-6979-40
Why was Fexofenadine Hydrochloride Tablets recalled?
Failed Impurities/Degradation Specifications
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?
Lot, expiry: Lot H00005, exp 01/2022; Lot H00006, exp 04/2022; Lot H00007, exp 07/2022
- Product
- Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 NDC 0904-6979-40
- Recalling firm
- The Harvard Drug Group
- Quantity
- 2,239 bottles
- Distribution
- Nationwide USA
- Recall date
- December 29, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)