CLASS II Drug recall · Reported 4 Nov 2015 · FDA Enforcement Report
Tri-mix 10MCG+0.5MG+15MG/ML vial recalled by Chen Shwezin
Chen Shwezin is recalling Tri-mix 10MCG+0.5MG+15MG/ML vial, distributed in California. The recall was initiated on 6 Oct 2015 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0158-2016
- FDA event ID
- 72402
- Recalling firm
- Chen Shwezin, Westlake Village, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Oct 2015
- FDA classified
- 28 Oct 2015
- Reported
- 4 Nov 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 6 Oct 2015 | Recall initiated by company | |
| 28 Oct 2015 | Classified by FDA | +22 days |
| 4 Nov 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: all sterile compounded products within expiry
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
TRI-MIX 10MCG+0.5MG+15MG/ML,5 mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA 91362, (805) 497-8258
Where it was distributed
CA
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: all sterile compounded products within expiry
Which lots are affected?
Lot# 09152015@8, Exp, 10/15/15
Where was it sold?
CA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 72402This product is part of a recall event; the main page for the event is Tri-mix 20MCG+0.5MG+15MG/ML vial recalled by Chen Shwezin.
More recalls from Chen Shwezin
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Prostaglandin Pge-1 40MCG/ML vial recalled by Chen Shwezin | Chen Shwezin | Sterility | CA |
| Drug | CLASS II | Caffeine + Sodium Benzoate 500MG/ML vial recalled by Chen Shwezin | Chen Shwezin | Sterility | CA |
| Drug | CLASS II | Methylcobalamin 1000MCG/ML vial recalled by Chen Shwezin | Chen Shwezin | Sterility | CA |
| Drug | CLASS II | Tri-mix 20MCG+0.5MG+15MG/ML vial recalled by Chen Shwezin | Chen Shwezin | Sterility | CA |
Other Tri-mix + + recalls
All 18| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tri-mix 20MCG+0.5MG+15MG/ML vial recalled by Chen Shwezin | Chen Shwezin | Sterility | CA |
| Drug | CLASS II | Tri-Mix (17.7 mg/1 mg/10 mcg) Injectable, Sterile recalled | The Compounding Pharmacy of America | Sterility | Nationwide |
| Drug | CLASS II | Tri-Mix (17 mg/0.5 mg/6 mcg) Injectable, Sterile recalled | The Compounding Pharmacy of America | Sterility | Nationwide |
| Drug | CLASS II | Tri-Mix (15 mg/0.5 mg/5 mcg) Injectable, Sterile recalled | The Compounding Pharmacy of America | Sterility | Nationwide |
| Drug | CLASS II | Tri-Mix Injectable, The Compounding Pharmacy of America recalled | The Compounding Pharmacy of America | Sterility | Nationwide |