FDAClass IIJanuary 17, 2018

Chloramphenicol 50 mg/ Sulfamethoxazole 50 mg recall: Labeling Error

Chloramphenicol 50 mg/ Sulfamethoxazole 50 mg/ Amphotericin-B 5 mg capsules, For OTIC Use Only, Rx Only, KRS Global Biotechnology, 791 Park of…

Why was Chloramphenicol 50 mg/ Sulfamethoxazole 50 mg recalled?

Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

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: 08212017@24 BUD: 2/17/2018

Product
Chloramphenicol 50 mg/ Sulfamethoxazole 50 mg/ Amphotericin-B 5 mg capsules, For OTIC Use Only, Rx Only, KRS Global Biotechnology, 791 Park of…
Recalling firm
KRS Global Biotechnology, Inc
Quantity
90 capsules
Distribution
Nationwide in the USA, Bermuda, and New Zealand
Recall date
January 17, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls