Drug Enforcement D-0489-2024

Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count tramadol

Status

Terminated

Classification

Class II

Report Date

May 15, 2024

Termination Date

September 9, 2024

Product Information

Product description
TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824-00; (b) 90-count blister pack, NDC 70518-3824-02; (a) 180-count blister pack, NDC 70518-3824-03; RX ONLY, MFG: Advagen Pharma Limited, Plainsboro. NJ 08536, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, 724.465.8762
Product quantity
23,970 Tablets
Reason for recall
Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count tramadol
Recall initiation reason
—
Initial firm notification
E-Mail
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
RemedyRepack Inc.
Address
625 Kolter Dr Ste 4, N/A

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

Codes & Dates

Recall number
D-0489-2024
Event ID
94567
Recall initiation date
May 2, 2024
Center classification date
May 8, 2024
Code info
Lots#: (a)J0732085-101023, Exp (b) B2546618-100523, Exp (c) B2546541-100523
More code info
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