Multi-event March 2014 FDA Recall Paroxetine Hydrochloride by Apotex Inc.

This Multi-event Class II drug recall was voluntarily initiated by Apotex Inc. on March 24, 2014 for the product Paroxetine Hydrochloride. The FDA reported the reason for recall as chemical contamination. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1581-2014 TERMINATED D-1580-2014 TERMINATED D-1577-2014 TERMINATED D-1575-2014 TERMINATED D-1582-2014 TERMINATED D-1579-2014 TERMINATED D-1578-2014 TERMINATED D-1576-2014 TERMINATED D-1574-2014 TERMINATED

Recall Number: D-1581-2014

Reason for Recall
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Initiated
03-24-2014
Reported
09-10-2014
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68967
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Apotex Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-23-2014
Product Description About Product Description
Full technical description of the product.
PAXIL (Paroxetine HCL) Tablets 20 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3664-3

Batch or Lot Expiration Information

Lot# 2ZP5499, Exp. 02/15

Recall Number: D-1580-2014

Reason for Recall
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Initiated
03-24-2014
Reported
09-10-2014
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68967
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Apotex Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-23-2014
Product Description About Product Description
Full technical description of the product.
PAXIL (Paroxetine HCL) Tablets 10 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3663-3

Batch or Lot Expiration Information

Lot# 2ZP7113, Exp. 08/15

Recall Number: D-1577-2014

Reason for Recall
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Initiated
03-24-2014
Reported
09-10-2014
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68967
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Apotex Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-23-2014
Product Description About Product Description
Full technical description of the product.
Paroxetine HCL Controlled-Release Tablets 37.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3675-3

Batch or Lot Expiration Information

Lot# 2C002, Exp. 03/15
Lot# 2H004, Exp. 08/15
Lot# 2H006, Exp. 08/15

Affected Packages Involved in this Recall

60505-1316-3 Paroxetine Hydrochloride
60505-1317-3 Paroxetine Hydrochloride
60505-1318-3 Paroxetine Hydrochloride
60505-3673-3 Paroxetine Hydrochloride
60505-3674-3 Paroxetine Hydrochloride
60505-3675-3 Paroxetine Hydrochloride

Recall Number: D-1575-2014

Reason for Recall
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Initiated
03-24-2014
Reported
09-10-2014
Quantity
13,429 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68967
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Apotex Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-23-2014
Product Description About Product Description
Full technical description of the product.
PAXIL (Paroxetine HCL) Oral Suspension 10 mg/5 mL - 250 mL bottle, Rx Only, Manufactured by GlaxoSmithKline, RTP, NC 27709. Distributed by Apotex Corp., Westin, FL 33326, NDC 60505-0402-5

Batch or Lot Expiration Information

Lot# 2A001, Exp. 01/15
Lot# 2C002, Exp. 03/15

Recall Number: D-1582-2014

Reason for Recall
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Initiated
03-24-2014
Reported
09-10-2014
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68967
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Apotex Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-23-2014
Product Description About Product Description
Full technical description of the product.
PAXIL (Paroxetine HCL) Tablets 40 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3666-3

Batch or Lot Expiration Information

Lot# 2ZP3908, Exp. 05/15

Recall Number: D-1579-2014

Reason for Recall
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Initiated
03-24-2014
Reported
09-10-2014
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68967
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Apotex Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-23-2014
Product Description About Product Description
Full technical description of the product.
PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 37.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3670-3

Batch or Lot Expiration Information

Lot# 2E001; Exp. 05/15

Affected Packages Involved in this Recall

60505-4377-3 Paxil Cr
60505-4378-3 Paxil Cr
60505-4379-3 Paxil Cr
60505-3668-3 Paxil Cr
60505-3669-3 Paxil Cr
60505-3670-3 Paxil Cr

Recall Number: D-1578-2014

Reason for Recall
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Initiated
03-24-2014
Reported
09-10-2014
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68967
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Apotex Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-23-2014
Product Description About Product Description
Full technical description of the product.
PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3669-3

Batch or Lot Expiration Information

Lot# 2F004, Exp. 06/15

Affected Packages Involved in this Recall

60505-4377-3 Paxil Cr
60505-4378-3 Paxil Cr
60505-4379-3 Paxil Cr
60505-3668-3 Paxil Cr
60505-3669-3 Paxil Cr
60505-3670-3 Paxil Cr

Recall Number: D-1576-2014

Reason for Recall
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Initiated
03-24-2014
Reported
09-10-2014
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68967
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Apotex Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-23-2014
Product Description About Product Description
Full technical description of the product.
Paroxetine HCL Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3674-3

Batch or Lot Expiration Information

Lot# 2A002, Exp. 01/15
Lot# 2A003, Exp. 01/15
Lot# 2C004, Exp. 03/15
Lot# 2C005, Exp. 03/15
Lot# 2E008, Exp. 05/15
Lot# 2F009, Exp. 06/15
Lot# 2F010, Exp. 06/15
Lot# 2H011, Exp. 08/15
Lot# 2H012, Exp. 08/15
Lot# 2H013, Exp. 0815

Affected Packages Involved in this Recall

60505-1316-3 Paroxetine Hydrochloride
60505-1317-3 Paroxetine Hydrochloride
60505-1318-3 Paroxetine Hydrochloride
60505-3673-3 Paroxetine Hydrochloride
60505-3674-3 Paroxetine Hydrochloride
60505-3675-3 Paroxetine Hydrochloride

Recall Number: D-1574-2014

Reason for Recall
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Initiated
03-24-2014
Reported
09-10-2014
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68967
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Apotex Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-23-2014
Product Description About Product Description
Full technical description of the product.
Paroxetine HCL Controlled-Release Tablets 12.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3673-3

Batch or Lot Expiration Information

Lot# 2A001, Exp. 01/15
Lot# 2A002, Exp. 01/15
Lot# 2C003, Exp. 03/15
Lot# 2F005, Exp. 06/15
Lot# 2G006, Exp. 07/15

Affected Packages Involved in this Recall

60505-1316-3 Paroxetine Hydrochloride
60505-1317-3 Paroxetine Hydrochloride
60505-1318-3 Paroxetine Hydrochloride
60505-3673-3 Paroxetine Hydrochloride
60505-3674-3 Paroxetine Hydrochloride
60505-3675-3 Paroxetine Hydrochloride