FDA (Drugs) recall action 68967

Apotex Inc. recalled 9 products on 2014-09-10

The FDA (Drugs) publishes a recall like this one as 9 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 9 pages.

Products: 9
Announced: 2014-09-10
Critical: 0
Units: 13,429

Why these products were recalled

Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–9 of 9

SevereFDA (Drugs)··2014-09-10
Apotex Recalls PAXIL Oral Suspension Due to Chemical Contamination
Apotex Inc. is recalling PAXIL (Paroxetine HCL) Oral Suspension because it was manufactured with active pharmaceutical ingredient batches contaminated with residual materials and solvents.
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
Category
Distribution
1 state
SevereFDA (Drugs)··2014-09-10
Apotex Recalls PAXIL CR Tablets Due to Chemical Contamination
Apotex Inc. is recalling PAXIL CR tablets because they were manufactured with active pharmaceutical ingredient batches contaminated with residual materials and solvents.
Product
PAXIL (PAROXETINE HYDROCHLORIDE)
Category
Distribution
1 state
SevereFDA (Drugs)··2014-09-10
Apotex Recalls PAXIL Tablets Due to Chemical Contamination
Apotex Inc. is recalling PAXIL (Paroxetine HCL) 40 mg tablets due to contamination with residual materials and solvents.
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
Category
Distribution
1 state
SevereFDA (Drugs)··2014-09-10
Apotex Recalls Paroxetine Hydrochloride Tablets Due to Chemical Contamination
Apotex Inc. is recalling Paroxetine Hydrochloride Controlled-Release Tablets because they were manufactured with active pharmaceutical ingredient batches contaminated with residual materials and solvents.
Product
PAROXETINE HYDROCHLORIDE (PAROXETINE HYDROCHLORIDE)
Category
Distribution
1 state
SevereFDA (Drugs)··2014-09-10
Apotex Recalls PAXIL Tablets Due to Chemical Contamination
Apotex Inc. is recalling PAXIL (Paroxetine HCL) 10 mg tablets because they were manufactured with active pharmaceutical ingredient batches contaminated with residual materials and solvents.
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
Category
Distribution
1 state
SevereFDA (Drugs)··2014-09-10
Apotex Recalls PAXIL Tablets Due to Chemical Contamination
Apotex Inc. is recalling specific lots of PAXIL (Paroxetine HCL) 20 mg tablets because they were manufactured with active pharmaceutical ingredients contaminated with residual materials and solvents.
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
Category
Distribution
1 state
SevereFDA (Drugs)··2014-09-10
Apotex Recalls Paroxetine Hydrochloride Tablets Due to Chemical Contamination
Apotex Inc. is recalling specific lots of Paroxetine Hydrochloride Controlled-Release Tablets because they were manufactured with active pharmaceutical ingredient batches contaminated with residual materials and solvents.
Product
PAROXETINE HYDROCHLORIDE (PAROXETINE HYDROCHLORIDE)
Category
Distribution
1 state
HighFDA (Drugs)··2014-09-10
Apotex Recalls Paroxetine Hydrochloride Tablets Due to Chemical Contamination
Apotex Inc. is recalling Paroxetine Hydrochloride Controlled-Release Tablets 25 mg because they were manufactured with active pharmaceutical ingredient batches contaminated with residual materials and solvents.
Product
PAROXETINE HYDROCHLORIDE (PAROXETINE HYDROCHLORIDE)
Category
Distribution
1 state
SevereFDA (Drugs)··2014-09-10
Apotex Recalls PAXIL Tablets Due to Chemical Contamination
Apotex Inc. is recalling PAXIL CR tablets because they were manufactured with active pharmaceutical ingredients contaminated with residual materials and solvents.
Product
PAXIL (PAROXETINE HYDROCHLORIDE)
Category
Distribution
1 state