Class II · Moderate risk
Procaine HCL 2%
Lack of Assurance of Sterility
Procaine Penicillin G active pharmaceutical ingredient packaged…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Stability Data Does Not Support Expiry: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged without data to support the printed expiry date.
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What was recalled
Procaine Penicillin G 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: Procaine Category: Antibiotic
- Recalling firm
- Attix Pharmaceuticals
- Origin
- Canada
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-865-2015 · 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 Procaine recalls
See all
Class II · Moderate risk
S-Procaine HCL 2% Buffered
Lack of Assurance of Sterility
Class II · Moderate risk
S-Procaine HCL 1% Buffered Mdv
Lack of Assurance of Sterility
Class II · Moderate risk
Prostaglandin 20 mcg/mL/Procaine 0.1% Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
Procaine HCL 8%
Lack of Assurance of Sterility
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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