Paroxetine Tablet, Film Coated
FDA Recall NDC 60505-0101
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 4 recorded enforcement report(s) associated with Paroxetine (NDC 60505-0101). A significant event, classified as Class II, was initiated on Nov 01, 2023 by Apotex Corp.. The reported reason for this action was: "Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
November 2023 Class II Recall: Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Recall Number
Class II Ongoing
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Nov 01, 2023
Dec 06, 2023
34,392
Recall Profile & Regulatory Data
Event ID
93353
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Apotex Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#: 60505-0097-1; b) 100-count bottle, NDC#: 60505-0097-2; c) 1000-count bottle, NDC#: 60505-0097-4, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.
Batch or Lot Expiration Information
Lot# Lot numbers: a)100 count bottle: RV2376, RV2377; b) 1000 count bottle: RV2379, RV2380; c) 30 count bottle: RV2375; Exp. 08/2024
Affected Packages Involved in this Recall
60505-0097-1Product
60505-0097-9Product
60505-0097-2Product
60505-0097-4Product
60505-0097-7Product
60505-0097-5Product
60505-0083-1Product
60505-0083-9Product
60505-0083-2Product
60505-0083-4Product
60505-0083-0Product
60505-0083-5Product
60505-0084-1Product
60505-0084-9Product
60505-0084-2Product
60505-0084-4Product
60505-0084-5Product
60505-0101-1Product
60505-0101-9Product
60505-0101-2Product
60505-0101-4Product
60505-0101-5Product
60505-0101-7Product
November 2023 Class II Recall: Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Recall Number
Class II Ongoing
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Nov 01, 2023
Dec 06, 2023
4,074
Recall Profile & Regulatory Data
Event ID
93353
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Apotex Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#:60505-0101-4 Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.
Batch or Lot Expiration Information
Lot# Lot numbers: RV0131, RV2387, RV2389, RW3296, RV2388; Exp. 08/2024
Affected Packages Involved in this Recall
60505-0097-1Product
60505-0097-9Product
60505-0097-2Product
60505-0097-4Product
60505-0097-7Product
60505-0097-5Product
60505-0083-1Product
60505-0083-9Product
60505-0083-2Product
60505-0083-4Product
60505-0083-0Product
60505-0083-5Product
60505-0084-1Product
60505-0084-9Product
60505-0084-2Product
60505-0084-4Product
60505-0084-5Product
60505-0101-1Product
60505-0101-9Product
60505-0101-2Product
60505-0101-4Product
60505-0101-5Product
60505-0101-7Product
November 2023 Class II Recall: Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Recall Number
Class II Ongoing
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Nov 01, 2023
Dec 06, 2023
25,776
Recall Profile & Regulatory Data
Event ID
93353
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Apotex Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
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.
Batch or Lot Expiration Information
Lot# Lot numbers: a)100 count bottle: RV8686; b) 1000 count bottle: RX0119; c) 30 count bottle: RV2254; Exp. 08/2024
Affected Packages Involved in this Recall
60505-0097-1Product
60505-0097-9Product
60505-0097-2Product
60505-0097-4Product
60505-0097-7Product
60505-0097-5Product
60505-0083-1Product
60505-0083-9Product
60505-0083-2Product
60505-0083-4Product
60505-0083-0Product
60505-0083-5Product
60505-0084-1Product
60505-0084-9Product
60505-0084-2Product
60505-0084-4Product
60505-0084-5Product
60505-0101-1Product
60505-0101-9Product
60505-0101-2Product
60505-0101-4Product
60505-0101-5Product
60505-0101-7Product
November 2023 Class II Recall: Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Recall Number
Class II Ongoing
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Nov 01, 2023
Dec 06, 2023
48,623
Recall Profile & Regulatory Data
Event ID
93353
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Apotex Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle, NDC#:60505-0083-2; b) 1000-count bottle, NDC#: 60505-0083-4 Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.
Batch or Lot Expiration Information
Lot# Lot numbers: a)100 count bottle: RV2384, RV2385; b) 1000 count bottle: RV2396, RV2397; Exp. 08/2024
Affected Packages Involved in this Recall
60505-0097-1Product
60505-0097-9Product
60505-0097-2Product
60505-0097-4Product
60505-0097-7Product
60505-0097-5Product
60505-0083-1Product
60505-0083-9Product
60505-0083-2Product
60505-0083-4Product
60505-0083-0Product
60505-0083-5Product
60505-0084-1Product
60505-0084-9Product
60505-0084-2Product
60505-0084-4Product
60505-0084-5Product
60505-0101-1Product
60505-0101-9Product
60505-0101-2Product
60505-0101-4Product
60505-0101-5Product
60505-0101-7Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
