FDA (Drugs) recall action 70452

Attix Pharmaceuticals recalled 470 products on 2015-04-29

The FDA (Drugs) publishes a recall like this one as 470 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 470 pages.

Products: 470
Announced: 2015-04-29
Critical: 0
Units: 2,350

Why these products were recalled

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Penicillin Cross Contamination: All lots of all products repackaged between 01/05/12 through 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Stability Data Does Not Support Expiry: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged without data to support the printed expiry date.

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.

1–25 of 470

SevereFDA (Drugs)··2015-04-29
Attix Pharmaceuticals Recalls Satraplatin Due to Penicillin Cross Contamination Risk
Attix Pharmaceuticals is recalling Satraplatin active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.
Product
Satraplatin active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
Category
Distribution
0 states
SevereFDA (Drugs)··2015-04-29
Attix Pharmaceuticals Recalls Hydralazine HCl Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Hydralazine HCl active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.
Product
Hydralazine HCl active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
Category
Distribution
0 states
SevereFDA (Drugs)··2015-04-29
Attix Pharmaceuticals Recalls Levocetirizine HCl Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Levocetirizine HCl active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.
Product
Levocetirizine HCl active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
Category
Distribution
0 states
SevereFDA (Drugs)··2015-04-29
Attix Pharmaceuticals Recalls Amikacin Sulfate Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Amikacin Sulfate active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.
Product
Amikacin Sulfate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
Category
Distribution
0 states
SevereFDA (Drugs)··2015-04-29
Attix Pharmaceuticals Recalls Paroxetine HCl Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Paroxetine HCl active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.
Product
Paroxetine HCl active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
Category
Distribution
0 states
SevereFDA (Drugs)··2015-04-29
Progesterone API Recalled for Potential Penicillin Cross Contamination
Attix Pharmaceuticals is recalling progesterone active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.
Product
Progesterone active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
Category
Distribution
0 states
SevereFDA (Drugs)··2015-04-29
Attix Pharmaceuticals Recalls Dantrolene Sodium Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Dantrolene Sodium API lots distributed between January 2012 and February 2015 due to potential penicillin cross-contamination from inadequate facility separation.
Product
Dantrolene Sodium (Light Yellow) active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
Category
Distribution
0 states
SevereFDA (Drugs)··2015-04-29
Attix Pharmaceuticals Recalls Acetylsalicyclic Acid Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling acetylsalicyclic acid active pharmaceutical ingredient due to potential penicillin cross-contamination. The product was distributed to compounding pharmacies and research organizations.
Product
Acetylsalicyclic acid active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
Category
Distribution
0 states
HighFDA (Drugs)··2015-04-29
Attix Pharmaceuticals Recalls Rebamipide Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling all lots of Rebamipide API distributed between January 2012 and February 2015 due to potential penicillin cross-contamination from inadequate facility separation.
Product
Rebamipide active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
Category
Distribution
0 states
HighFDA (Drugs)··2015-04-29
Progesterone API Recalled for Potential Penicillin Cross-Contamination
Attix Pharmaceuticals is recalling progesterone active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.
Product
Progesterone Ultra-Micronized active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
Category
Distribution
0 states
HighFDA (Drugs)··2015-04-29
Attix Pharmaceuticals Recalls Paroxetine Active Ingredient Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling paroxetine active pharmaceutical ingredient repackaged between January 2012 and February 2015 due to potential penicillin cross-contamination.
Product
Paroxetine active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
Category
Distribution
0 states
HighFDA (Drugs)··2015-04-29
Attix Pharmaceuticals Recalls Bismuth Subcarbonate Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Bismuth Subcarbonate active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.
Product
Bismuth Subcarbonate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
Category
Distribution
0 states
SevereFDA (Drugs)··2015-04-29
Attix Pharmaceuticals Recalls Furazolidine Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Furazolidine active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.
Product
Furazolidine active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
Category
Distribution
0 states
SevereFDA (Drugs)··2015-04-29
Attix Pharmaceuticals Recalls Quinine Sulfate Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Quinine Sulfate Dihydrate active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.
Product
Quinine Sulfate Dihydrate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
Category
Distribution
0 states
SevereFDA (Drugs)··2015-04-29
Attix Pharmaceuticals Recalls Histamine Phosphate Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Histamine Phosphate active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.
Product
Histamine Phosphate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
Category
Distribution
0 states
SevereFDA (Drugs)··2015-04-29
Attix Pharmaceuticals Recalls Cisatracurium Besylate Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Cisatracurium Besylate active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.
Product
Cisatracurium Besylate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
Category
Distribution
0 states
SevereFDA (Drugs)··2015-04-29
Attix Pharmaceuticals Recalls Etomidate Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Etomidate active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.
Product
Etomidate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
Category
Distribution
0 states
SevereFDA (Drugs)··2015-04-29
Attix Pharmaceuticals Recalls Cimetidine API Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Cimetidine active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.
Product
Cimetidine active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
Category
Distribution
0 states
SevereFDA (Drugs)··2015-04-29
Attix Pharmaceuticals Recalls Estradiol Due to Penicillin Cross Contamination Risk
Attix Pharmaceuticals is recalling Estradiol (Micronized) active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.
Product
Estradiol (Micronized) active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
Category
Distribution
0 states
HighFDA (Drugs)··2015-04-29
Attix Pharmaceuticals Recalls Chloroquine Phosphate Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Chloroquine Phosphate active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.
Product
Chloroquine Phosphate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
Category
Distribution
0 states
HighFDA (Drugs)··2015-04-29
Attix Pharmaceuticals Recalls Anastrozole API Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Anastrozole active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.
Product
Anastrozole active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
Category
Distribution
0 states
HighFDA (Drugs)··2015-04-29
Attix Pharmaceuticals Recalls Povidone K-30 Ingredient Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Povidone K-30 pharmaceutical ingredient lots distributed between January 2012 and February 2015 due to potential penicillin cross-contamination.
Product
Povidone K-30 pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
Category
Distribution
0 states
SevereFDA (Drugs)··2015-04-29
Fluorexon API Recalled for Potential Penicillin Cross Contamination
Attix Pharmaceuticals is recalling Fluorexon active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.
Product
Fluorexon active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
Category
Distribution
0 states
SevereFDA (Drugs)··2015-04-29
Attix Pharmaceuticals Recalls Vidarbine Monophosphate Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Vidarbine Monophosphate active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.
Product
Vidarbine Monophosphate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
Category
Distribution
0 states
SevereFDA (Drugs)··2015-04-29
Attix Pharmaceuticals Recalls Tiopronin Base Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Tiopronin Base active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.
Product
Tiopronin Base active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
Category
Distribution
0 states