Class II · Moderate risk
Promethazine HCl Oral Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Promethazine 12.5mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Braun PAB bag
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Promethazine 12.5mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Braun PAB bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0186-41
Affected NDC
45183-0186-41
Compare with the code on your package — it is the most precise check available.
Drug: Promethazine
- Recalling firm
- Pharmakon Pharmaceuticals, Inc.
- NDC code
- 45183-0186-41
- Origin
- IN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1275-2016 · 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 Promethazine recalls
See all
Class II · Moderate risk
Promethazine HCl & Codeine Phosphate Oral Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Promethazine HCl Tablets
cGMP deviations: Temperature abuse
Class II · Moderate risk
Promethazine HCl Topical Ointment
CGMP Deviations
Class II · Moderate risk
Promethazine With Codeine Oral Solution
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Other recalls by Pharmakon Pharmaceuticals, Inc.
All 2016 recalls
Class II · Moderate risk
Sufentanil Citrate 0.4mcg/mL & Bupivacaine 0.1% in 0.9% Sodium…
Lack of Assurance of Sterility
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
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