FDA Recall D-0487-2024

Rubicon Research Private Limited · Ambarnath, N/A

Class II Ongoing 748 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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

Lot / code: Lot #: 230774Hl, Exp 4/30/2026

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 record

Recall number: D-0487-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2024-04-26
Classified by FDA Center: 2024-05-07
FDA published: 2024-05-15
Recalling firm: Rubicon Research Private Limited
Firm location: Ambarnath, N/A, India

Drug identification

Brand name(s): TRAMADOL HYDROCHLORIDE
Generic name(s): TRAMADOL HYDROCHLORIDE
Manufacturer(s): Advagen Pharma Limited
NDC(s): 72888-008, 72888-162, 72888-080, 72888-163
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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