FDAClass IIMarch 6, 2013

Isoniazid Tablets 300 mg tablets USP recall: Failed Dissolution

Isoniazid Tablets 300 mg tablets USP, Rx Only, a) 30 tablets - NDC 61748-013-30, b) 100 tablets - NDC 61748-013-01, Mfd for: VersaPharm Incorporated…

Why was Isoniazid Tablets 300 mg tablets USP recalled?

Failed Dissolution Specifications; 36 month stability timepoint

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?

67079A; 67079B; 67079C

Product
Isoniazid Tablets 300 mg tablets USP, Rx Only, a) 30 tablets - NDC 61748-013-30, b) 100 tablets - NDC 61748-013-01, Mfd for: VersaPharm Incorporated…
Recalling firm
West-ward Pharmaceutical Corp.
Quantity
77531 bottles
Distribution
GA
Recall date
March 6, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls