Drug Enforcement D-0001-2025

Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.

Status

Ongoing

Classification

Class II

Report Date

October 9, 2024

Termination Date

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Product Information

Product description
Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827, USA, Manufactured by: Umedica Laboratories Pvt Ltd., Vapi Gujarat 396195, India, NDC: 75834-257-01.
Product quantity
2328 bottles
Reason for recall
Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.
Recall initiation reason
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Initial firm notification
E-Mail
Distribution pattern
Nationwide within the U.S

Location & Firm

Recalling firm
Nivagen Pharmaceuticals Inc
Address
3100 Fite Cir, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0001-2025
Event ID
95418
Recall initiation date
September 24, 2024
Center classification date
October 2, 2024
Code info
Lot #: U24T0408A, Exp: 03/31/2026
More code info
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