Drug recall: 5-Aminolevulinic Acid Hydrochloride active pharmaceutical ingredient packaged in varying grams or kg in bags or drums…
Class II FDA enforcement event 70452. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
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
Attix Pharmaceuticals started this drug recall on 14 Nov 2014. The firm address in the FDA record is in Toronto. FDA put the recall in Class II. FDA event 70452 has 470 product records. The first FDA enforcement report date is 29 Apr 2015. The record gives the status Terminated, with the termination date 7 Oct 2015.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide to compounding pharmacies and research organizations.
Recalling firm
Attix Pharmaceuticals, Toronto, Canada.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
470 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-491-2015 | 5-Aminolevulinic Acid 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 | 510 grams | Class II | Terminated | 29 Apr 2015 |
| D-492-2015 | 4-Aminopyridine 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 | 1310 grams | Class II | Terminated | 29 Apr 2015 |
| D-493-2015 | 2-Deoxy-D-Glucose active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, On | 3100 grams | Class II | Terminated | 29 Apr 2015 |
| D-494-2015 | 3,4-Diaminopyridine 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 | 375 grams | Class II | Terminated | 29 Apr 2015 |
| D-495-2015 | 2,3-Dimercaptopropanesulfonic Acid Sodium Salt (DMPS) 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 | 1480 grams | Class II | Terminated | 29 Apr 2015 |
| D-496-2015 | 2,3-Dimercaptosuccinic Acid (DMSA) 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 | 9625 grams | Class II | Terminated | 29 Apr 2015 |
| D-497-2015 | 5-Fluorouracil 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 | 1000 grams | Class II | Terminated | 29 Apr 2015 |
| D-498-2015 | 2-Methoxyestradiol 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 | 90 grams | Class II | Terminated | 29 Apr 2015 |
| D-499-2015 | Acetazolamide 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 | 2100 grams | Class II | Terminated | 29 Apr 2015 |
| D-500-2015 | 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 | 1000 grams | Class II | Terminated | 29 Apr 2015 |
| D-501-2015 | Acyclovir 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 | 1000 grams | Class II | Terminated | 29 Apr 2015 |
| D-502-2015 | Adapalene 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 | 25 grams | Class II | Terminated | 29 Apr 2015 |
| D-503-2015 | Adenosine 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 | 1000 grams | Class II | Terminated | 29 Apr 2015 |
| D-504-2015 | Albendazole 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 | 10065 grams | Class II | Terminated | 29 Apr 2015 |
| D-505-2015 | Albumin (Bovine) 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 | 500 grams | Class II | Terminated | 29 Apr 2015 |
| D-506-2015 | Albuterol 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 | 1890 grams | Class II | Terminated | 29 Apr 2015 |
| D-507-2015 | Aldosterone 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 | 16 grams | Class II | Terminated | 29 Apr 2015 |
| D-508-2015 | Alpha Chymotrypsin 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 | 100 grams | Class II | Terminated | 29 Apr 2015 |
| D-509-2015 | Amantadine 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 | 23000 grams | Class II | Terminated | 29 Apr 2015 |
| D-510-2015 | Ambroxol 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 | 2000 grams | Class II | Terminated | 29 Apr 2015 |
| D-511-2015 | 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 | 7500 grams | Class II | Terminated | 29 Apr 2015 |
| D-512-2015 | 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 | 25 grams | Class II | Terminated | 29 Apr 2015 |
| D-513-2015 | Aminocaproic 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 | 100000 grams | Class II | Terminated | 29 Apr 2015 |
| D-514-2015 | 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 | 11600 grams | Class II | Terminated | 29 Apr 2015 |
| D-515-2015 | Aminopyridine 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 | 2000 grams | Class II | Terminated | 29 Apr 2015 |
| D-516-2015 | Amitriptyline 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 | 6050 grams | Class II | Terminated | 29 Apr 2015 |
| D-517-2015 | Amlodipine 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 | 1000 grams | Class II | Terminated | 29 Apr 2015 |
| D-518-2015 | Amlodipine 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 | 5200 grams | Class II | Terminated | 29 Apr 2015 |
| D-519-2015 | Ammonium Tetrathiomolybdate 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 | 200 grams | Class II | Terminated | 29 Apr 2015 |
| D-520-2015 | 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 | 100 grams | Class II | Terminated | 29 Apr 2015 |
| D-521-2015 | 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 | 5500 grams | Class II | Terminated | 29 Apr 2015 |
| D-522-2015 | 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 | 615 grams | Class II | Terminated | 29 Apr 2015 |
| D-523-2015 | Aprepitant 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 | 50 grams | Class II | Terminated | 29 Apr 2015 |
| D-524-2015 | Artemether 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 | 100 grams | Class II | Terminated | 29 Apr 2015 |
| D-525-2015 | Artesunate 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 | 1800 grams | Class II | Terminated | 29 Apr 2015 |
| D-526-2015 | 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 | 50 grams | Class II | Terminated | 29 Apr 2015 |
| D-527-2015 | Atomoxetine 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 | 200 grams | Class II | Terminated | 29 Apr 2015 |
| D-528-2015 | Atovaquone 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 | 3080 grams | Class II | Terminated | 29 Apr 2015 |
| D-529-2015 | Atropine Sulfate Monohydrate USP 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 | 7305 grams | Class II | Terminated | 29 Apr 2015 |
| D-530-2015 | Avanafil 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 | 1000 grams | Class II | Terminated | 29 Apr 2015 |
| D-531-2015 | Azatadine Maleate 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 | 50 grams | Class II | Terminated | 29 Apr 2015 |
| D-532-2015 | Azelastine 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 | 300 grams | Class II | Terminated | 29 Apr 2015 |
| D-533-2015 | Azithromycin 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 | 30316 grams | Class II | Terminated | 29 Apr 2015 |
| D-534-2015 | Baclofen 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 | 134535 grams | Class II | Terminated | 29 Apr 2015 |
| D-535-2015 | Belladonna Extract Powder 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 | 7800 grams | Class II | Terminated | 29 Apr 2015 |
| D-536-2015 | Benazepril 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 | 5 grams | Class II | Terminated | 29 Apr 2015 |
| D-537-2015 | Benazepril 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 | 3999 grams | Class II | Terminated | 29 Apr 2015 |
| D-538-2015 | Benoxinate 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 | 50 grams | Class II | Terminated | 29 Apr 2015 |
| D-539-2015 | Benztropine 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 | 100 grams | Class II | Terminated | 29 Apr 2015 |
| D-540-2015 | Betahistine Dihydrochloride 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 | 2000 grams | Class II | Terminated | 29 Apr 2015 |
| D-541-2015 | Betamethasone Sodium 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 | 75 grams | Class II | Terminated | 29 Apr 2015 |
| D-542-2015 | 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 | 250 grams | Class II | Terminated | 29 Apr 2015 |
| D-543-2015 | Bimatoprost 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 | 17 grams | Class II | Terminated | 29 Apr 2015 |
| D-544-2015 | Bisacodyl 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 | 50 grams | Class II | Terminated | 29 Apr 2015 |
| D-545-2015 | 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 | 25000 grams | Class II | Terminated | 29 Apr 2015 |
| D-546-2015 | Bovine Insulin 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 | 10 grams | Class II | Terminated | 29 Apr 2015 |
| D-547-2015 | Bromfenac 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 | 70 grams | Class II | Terminated | 29 Apr 2015 |
| D-548-2015 | Bromhexine 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 | 3000 grams | Class II | Terminated | 29 Apr 2015 |
| D-549-2015 | Bromocriptine 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 | 35 grams | Class II | Terminated | 29 Apr 2015 |
| D-550-2015 | Budesonide 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 | 3270 grams | Class II | Terminated | 29 Apr 2015 |
The table shows 60 of 470 product records. The FDA enforcement report lists all the records.
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Drug events that started in 2014
- 313
- Share of these events in Class II
- 58%
- Product records in this event
- 470
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report D-491-2015The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 70452. https://recallregister.com/fda/ii/70452/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide to compounding pharmacies and research organizations.
- What quantity of product is in FDA event 70452?
- The event has 470 product records. The first record gives this quantity:
510 grams
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2014 have the same class?
- 58% of the 313 drug events that started in 2014 are in Class II.