Class II · Moderate risk
Oxcarbazepine Oral Suspension
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Oxcarbazepine active pharmaceutical ingredient packaged in…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was 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.
Cause type: Cross-contamination
Traces of another drug - most often penicillin - got into the product from shared equipment or facilities. Even trace penicillin can trigger a severe allergic reaction in someone who was never meant to receive it. All cross-contamination recalls.
What was recalled
Oxcarbazepine 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
Drug: Oxcarbazepine
- Recalling firm
- Attix Pharmaceuticals
- Origin
- Canada
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-828-2015 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Oxcarbazepine recalls
See all
Class II · Moderate risk
Oxcarbazepine Tablets 600mg
Presence of foreign substance
Class II · Moderate risk
Oxcarbazepine Oral Suspension
Failed Impurities/Degradation Specificattion
Class I · High risk
Oxcarbazepine Tablets
Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets, 600mg drug product, were found to be mis-labeled with blister card print identifying the product as AHP Oxcarbazepine Tablets, 300mg, lot #142544.
Class II · Moderate risk
Oxcarbazepine Tablets
Failed Tablet Specifications: Broken Tablets Present.
Other recalls by Attix Pharmaceuticals
All 2014 recalls
Class III · Low risk
Mycophenolate Mofetil
cGMP deviation; manufacturer is Not Registered with the Food and Drug Administration
Class II · Moderate risk
Zonisamide active pharmaceutical ingredient packaged in varying…
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 · Moderate risk
Zolmitriptan active pharmaceutical ingredient packaged in varying…
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 · Moderate risk
Zoledronic Acid active pharmaceutical ingredient packaged in…
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.
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