Drug Enforcement D-0487-2024

Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol

Status

Ongoing

Classification

Class II

Report Date

May 15, 2024

Termination Date

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Product Information

Product description
traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distributed by: Advagen Pharma Limited, 666 Plainsboro Road Suite 605, Plainsboro, NJ, 08536, USA, Manufactured by: Rubicon Research, Private Limited, Ambernath, Dist. Thane, 421506 India NDC 72888-080-00
Product quantity
2,592 1000-count Bottles
Reason for recall
Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Rubicon Research Private Limited
Address
4 & K30 5 Plot No K - 30, District

India
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0487-2024
Event ID
94467
Recall initiation date
April 26, 2024
Center classification date
May 7, 2024
Code info
Lot #: 230774Hl, Exp 4/30/2026
More code info
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