Phenazopyridine Hydrochloride Tablets recall: CGMP Deviations
Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey…
Why was Phenazopyridine Hydrochloride Tablets recalled?
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
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 #: 28181501, 28181502, Exp 03/17; 28181503, 28181504, Exp 08/17; 28181505, 28181506, Exp 09/17; 28181601, Exp 01/18
- Product
- Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey…
- Recalling firm
- Nationwide Laboratories, LLC
- Quantity
- 5,786,653 tablets
- Distribution
- Nationwide in USA and Puerto Rico
- Recall date
- December 7, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)