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 through 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.

451–470 of 470

ModerateFDA (Drugs)··2015-04-29
Attix Pharmaceuticals Recalls Piperacillin Sodium Due to Missing Stability Data
Attix Pharmaceuticals is recalling Piperacillin Sodium active pharmaceutical ingredient because it was repackaged without data supporting the printed expiry date.
Product
Piperacillin Sodium 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 Estriol Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Estriol active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging. The product was distributed to compounding pharmacies and research organizations.
Product
Estriol 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 Metronidazole Base Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Metronidazole Base active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.
Product
Metronidazole 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
HighFDA (Drugs)··2015-04-29
Attix Pharmaceuticals Recalls Tamsulosin Base Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Tamsulosin Base active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.
Product
Tamsulosin 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
SevereFDA (Drugs)··2015-04-29
Attix Pharmaceuticals Recalls Etravirine API Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Etravirine active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.
Product
Etravirine 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 Citalopram Hydrobromide Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Citalopram Hydrobromide active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.
Product
Citalopram Hydrobromide 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
Terbinafine HCl Recalled for Potential Penicillin Cross-Contamination
Attix Pharmaceuticals is recalling Terbinafine HCl active pharmaceutical ingredient due to potential cross-contamination with penicillin during repackaging.
Product
Terbinafine 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
Tacrolimus Monohydrate Recalled for Potential Penicillin Cross Contamination
Attix Pharmaceuticals is recalling Tacrolimus Monohydrate active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.
Product
Tacrolimus Monohydrate 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 Mupirocin API Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Mupirocin active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.
Product
Mupirocin 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
Sildenafil Citrate Recalled for Potential Penicillin Cross Contamination
Attix Pharmaceuticals is recalling Sildenafil Citrate active pharmaceutical ingredient due to potential penicillin cross contamination during repackaging.
Product
Sildenafil Citrate 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
Amiloride HCl Recalled for Potential Penicillin Cross Contamination
Attix Pharmaceuticals is recalling Amiloride HCl active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.
Product
Amiloride 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 Domperidone API Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Domperidone active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.
Product
Domperidone 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 Aminophylline Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Aminophylline active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.
Product
Aminophylline 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 Pergolide Mesylate Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Pergolide Mesylate active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.
Product
Pergolide Mesylate 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 Digoxin Ingredient Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Digoxin active pharmaceutical ingredient repackaged between January 2012 and February 2015 due to potential penicillin cross-contamination.
Product
Digoxin 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 Tobramycin Base Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling all lots of Tobramycin Base distributed between January 2012 and February 2015 due to potential penicillin cross-contamination during repackaging.
Product
Tobramycin 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
HighFDA (Drugs)··2015-04-29
Attix Pharmaceuticals Recalls Celecoxib API Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling all lots of Celecoxib active pharmaceutical ingredient repackaged between January 2012 and February 2015 due to potential penicillin cross-contamination.
Product
Celecoxib 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
Primaquine Phosphate Recalled for Potential Penicillin Cross Contamination
Attix Pharmaceuticals is recalling Primaquine Phosphate active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.
Product
Primaquine 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
Atazanavir API Recalled for Potential Penicillin Cross Contamination
Attix Pharmaceuticals is recalling Atazanavir active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.
Product
Atazanavir 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
Miltefosine API Recalled for Potential Penicillin Cross Contamination
Attix Pharmaceuticals is recalling Miltefosine active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.
Product
Miltefosine 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