Drug Enforcement D-0121-2024

Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine

Status

Ongoing

Classification

Class II

Report Date

December 6, 2023

Termination Date

—

Product Information

Product description
Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 60505-0084-1, b)100-count bottle, NDC#:60505-0084-2, c)1000-count bottle, NDC#: 60505-0084-4, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.
Product quantity
25,776
Reason for recall
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Recall initiation reason
—
Initial firm notification
E-Mail
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Apotex Corp.
Address
2400 N Commerce Pkwy Ste 400

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

Codes & Dates

Recall number
D-0121-2024
Event ID
93353
Recall initiation date
November 1, 2023
Center classification date
November 27, 2023
Code info
Lot numbers: a)100 count bottle: RV8686; b) 1000 count bottle: RX0119; c) 30 count bottle: RV2254; Exp. 08/2024
More code info
—