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JB Chemicals and Pharmaceuticals Ltd: Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharm

DrugsSource: FDA (drug) · Date: 2026-07-29

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
JB Chemicals and Pharmaceuticals Ltd
Product
Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-401-10.
Reason / hazard
Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.
Classification
Class I
Status
Ongoing
Distribution / sold at
Nationwide in the USA
Recall initiated
2026-06-24
Code info
Lots: GY825029, GY825030, GY825031, GY825032, expires: 2028-OCT
Product quantity
34,020 100-count bottles.
Voluntary mandated
Voluntary: Firm initiated
City
Mumbai
State
N/A
Country
India
Event id
99321
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