FDAClass IISeptember 7, 2022

Neomycin Sulfate Tablets recall: Foreign Material

Neomycin Sulfate Tablets, USP 500 mg , 100-count bottles, Rx only, Distributed by: TEVA PHARMACEUTICALS USA, INC North Wales, PA 19454, NDC 0093-1177-01

Why was Neomycin Sulfate Tablets recalled?

CGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ingredient (API) used in the manufacture of Neomycin Sulfate Tablets, USP 500 mg.

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 #: 3007830, 3007746, 3007829, Exp. Date 10/2024

Product
Neomycin Sulfate Tablets, USP 500 mg , 100-count bottles, Rx only, Distributed by: TEVA PHARMACEUTICALS USA, INC North Wales, PA 19454, NDC 0093-1177-01
Recalling firm
Teva Pharmaceuticals USA Inc
Distribution
Nationwide within the United States
Recall date
September 7, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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