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.
Product description
Ofloxacin 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
Lot numbers, UPCs & expiration codes
All lots repackaged and distributed between 01/05/12 to 02/12/15
Where it was sold
Nationwide to compounding pharmacies and research organizations.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-821-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 14, 2014
- FDA report date
- Apr 29, 2015
- Quantity
- 1600 grams
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Attix Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-821-2015, exactly as published.
Show all FDA fields
- City
- Toronto
- Status
- Terminated
- Country
- Canada
- Event ID
- 70452
- Address
- 184 Front St E
- Address (line 2)
- unit 801
- Code information
- All lots repackaged and distributed between 01/05/12 to 02/12/15
- Report date
- Apr 29, 2015
- Product type
- Drugs
- Recall number
- D-821-2015
- Classification
- Class II
- Recalling firm
- Attix Pharmaceuticals
- Product quantity
- 1600 grams
- Termination date
- Oct 7, 2015
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ofloxacin 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
- Distribution pattern
- Nationwide to compounding pharmacies and research organizations.
- Recall initiation date
- Nov 14, 2014
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Apr 20, 2015