Drug Enforcement D-0939-2023

Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton indicating strength as 10 mg.

Status

Terminated

Classification

Class II

Report Date

July 26, 2023

Termination Date

September 17, 2024

Product Information

Product description
Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Made in India, NDC 72657-113-20.
Product quantity
19,968 bottles
Reason for recall
Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton indicating strength as 10 mg.
Recall initiation reason
—
Initial firm notification
N/A
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Glenmark Therapeutics, Inc.
Address
750 Corporate Dr, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0939-2023
Event ID
92565
Recall initiation date
May 1, 2023
Center classification date
July 21, 2023
Code info
FA2022001B, Exp 03/2025
More code info
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