Class II · Moderate risk
Sufentanil Citrate 0.4mcg/mL & Bupivacaine 0.1% in 0.9% Sodium…
Lack of Assurance of Sterility
Provocholine Pre-diluted Set II in 0.9% Sodium Chloride
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Stability data does not support expiry.
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
Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.25 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
- Recalling firm
- Pharmakon Pharmaceuticals
- Origin
- IN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0608-2016 · 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 recalls by Pharmakon Pharmaceuticals
All 2015 recalls
Class II · Moderate risk
Bupivacaine HCI 0.25% in 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
Midazolam HCl 1mg/mL in 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
Vecuronium 1mg/mL in Sterile Water
Lack of Assurance of Sterility
Other stability / shelf life recalls from 2015
All stability / shelf life recalls
Class III · Low risk
Ranitidine Syrup
Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.
Class II · Moderate risk
HEPARIN Sodium in 0.45% Sodium Chloride
Stability Data Does Not Support Expiry
Class II · Moderate risk
HEParin Sodium 0.5 USP UNITS/mL in 0.225% SODIUM CHLORIDE
Stability Data Does Not Support Expiry
Class II · Moderate risk
Provocholine Pre-diluted Set II in 0.9% Sodium Chloride
Stability data does not support expiry.
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