Class II · Moderate risk
Tri-Mix 20mcg+0.5mg+15mg/Ml
Lack of Assurance of Sterility: all sterile compounded products within expiry
Prostaglandin Pge-1 40mcg/Ml
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: all sterile compounded products within expiry
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
PROSTAGLANDIN PGE-1 40MCG/ML, 10mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA 91362, (805) 497-8258
- Recalling firm
- Chen Shwezin, Inc. dba Park Compounding Pharmacy
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0156-2016 · 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 Chen Shwezin, Inc. dba Park Compounding Pharmacy
All 2015 recalls
Class II · Moderate risk
Caffeine + Sodium Benzoate 500mg/Ml
Lack of Assurance of Sterility: all sterile compounded products within expiry
Class II · Moderate risk
Tri-Mix 10mcg+0.5mg+15mg/Ml
Lack of Assurance of Sterility: all sterile compounded products within expiry
Class II · Moderate risk
Methylcobalamin 1000mcg/Ml
Lack of Assurance of Sterility: all sterile compounded products within expiry
Other sterility / contamination recalls from 2015
All sterility / contamination recalls
Class I · High risk
Human Chorionic Gonadotropin
Non-sterility: presence of mold confirmed by outside laboratory at the 14 day culture.
Class II · Moderate risk
Baclofen
Lack of assurance of sterility
Class II · Moderate risk
IT Custom Compound
Lack of Assurance of Sterility
Class II · Moderate risk
Baclofen 1 mg/ml in 40 ml NS syringe
Lack of Assurance of Sterility
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