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JB Chemicals and Pharmaceuticals Ltd: Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & P

DrugsSource: FDA (drug) · Date: 2025-10-29

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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 10 mg, 500 Tablets bottles, 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 16571-402-50
Reason / hazard
Tablet/Capsules Imprinted with Wrong ID
Classification
Class III
Status
Ongoing
Distribution / sold at
U.S. Nationwide
Recall initiated
2025-09-12
Code info
Lot # PY925014, PY925013, Exp. 1/31/2028
Product quantity
13,440 bottles
Voluntary mandated
Voluntary: Firm initiated
City
Mumbai
Country
India
Event id
97573
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