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.

126–150 of 470

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 from inadequate facility separation.
Product
Estriol (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
SevereFDA (Drugs)··2015-04-29
Attix Pharmaceuticals Recalls Magnesium Stearate Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Magnesium Stearate pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.
Product
Magnesium Stearate 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 Nitazoxanide Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Nitazoxanide active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.
Product
Nitazoxanide 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 Rocuronium Bromide Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Rocuronium Bromide active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.
Product
Rocuronium Bromide 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
Amphotericin B Recalled for Potential Penicillin Cross Contamination
Attix Pharmaceuticals is recalling Amphotericin B active pharmaceutical ingredient due to potential cross contamination with penicillin during repackaging.
Product
Amphotericin B 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
Valacyclovir HCl Recalled for Potential Penicillin Cross Contamination
Attix Pharmaceuticals is recalling Valacyclovir HCl active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.
Product
Valacyclovir 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 Neostigmine Methylsulfate Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Neostigmine Methylsulfate active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.
Product
Neostigmine Methylsulfate 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 Methyl 5-Aminolevulinate Hydrochloride Due to Penicillin Contamination Risk
Attix Pharmaceuticals is recalling Methyl 5-Aminolevulinate Hydrochloride active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.
Product
Methyl 5-Aminolevulinate Hydrochloride 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 Tranexamic Acid Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Tranexamic Acid active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.
Product
Tranexamic 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
Flumazenil API Recalled for Potential Penicillin Cross Contamination
Attix Pharmaceuticals is recalling Flumazenil active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.
Product
Flumazenil 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 Cilostazol API Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling cilostazol active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.
Product
Cilostazol 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
Cabergoline API Recalled for Potential Penicillin Cross Contamination
Attix Pharmaceuticals is recalling Cabergoline active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.
Product
Cabergoline 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
Flumethasone API Recalled for Potential Penicillin Cross Contamination
Attix Pharmaceuticals is recalling Flumethasone active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.
Product
Flumethasone 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 Hydroxocobalamin Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Hydroxocobalamin Base active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.
Product
Hydroxocobalamin 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 Bethanechol Chloride Due to Penicillin Cross Contamination Risk
Attix Pharmaceuticals is recalling Bethanechol Chloride active pharmaceutical ingredient due to potential penicillin cross contamination from inadequate facility separation.
Product
Bethanechol Chloride 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 Lamotrigine Ingredient Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling lamotrigine active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.
Product
Lamotrigine 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 Everolimus API Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling all lots of everolimus active pharmaceutical ingredient distributed between January 2012 and February 2015 due to potential penicillin cross-contamination.
Product
Everolimus 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 Loratadine API Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Loratadine active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.
Product
Loratadine 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 Isoxsuprine HCl Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Isoxsuprine HCl active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.
Product
Isoxsuprine 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 Theophylline Anhydrous Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Theophylline Anhydrous active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.
Product
Theophylline Anhydrous 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 Montelukast Sodium Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Montelukast Sodium active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.
Product
Montelukast 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 Chloramphenicol Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Chloramphenicol active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.
Product
Chloramphenicol 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
ModerateFDA (Drugs)··2015-04-29
Attix Pharmaceuticals Recalls Amoxicillin Trihydrate Due to Missing Stability Data
Attix Pharmaceuticals is recalling Amoxicillin Trihydrate active pharmaceutical ingredient because stability data does not support the printed expiry dates.
Product
Amoxicillin Trihydrate 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
Simvastatin API Recalled for Potential Penicillin Cross Contamination
Attix Pharmaceuticals is recalling Simvastatin active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.
Product
Simvastatin 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 Doxycycline HCI Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Doxycycline HCI active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.
Product
Doxycycline HCI 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