Park Compounding TRI-MIX Recall: Sterility Risk
Park Compounding Pharmacy recalls specific TRI-MIX vials due to lack of sterility assurance. Check lot numbers and expiration dates immediately.
Use caution until it’s fixed
Lack of Assurance of Sterility: all sterile compounded products within expiry
Contact the company
What happened, in plain English
Park Compounding Pharmacy is recalling TRI-MIX 20MCG+0.5MG+15MG/ML in 10 mL vials because there is a lack of assurance of sterility for all sterile compounded products within their expiry date. This recall affects a very small quantity of product distributed in California. The record does not specify a remedy or action steps for consumers. Read more at govinfonow.com/recall/43599-chen-shwezin-inc-dba-park-compounding-pharmacy-recalls-tri-mix.
Source Summary by GovInfoNow · govinfonow.com/recall/43599-chen-shwezin-inc-dba-park-compounding-pharmacy-recalls-tri-mix · Updated October 12, 2026 · FDA enforcement record: FDA #D-0160-2016
Cite this page
“Park Compounding TRI-MIX Recall: Sterility Risk.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/43599-chen-shwezin-inc-dba-park-compounding-pharmacy-recalls-tri-mix. Based on FDA recall #D-0160-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0160-2016%22&limit=1).
Why it’s dangerous
The primary hazard is a lack of assurance that the sterile compounded products remained sterile within their expiry date. If the sterility was compromised, using the injection could introduce bacteria or other contaminants into the body, leading to serious infection.
Who’s affected
Patients in California who were prescribed this specific compounded medication by Park Compounding Pharmacy are likely affected. Because the hazard involves sterility, there is a potential risk of infection if the product was used.
How to tell if you have this one
Look for TRI-MIX 20MCG+0.5MG+15MG/ML in a 10 mL vial labeled Rx only. The product was distributed by Park Compounding Pharmacy at 280 N. Westlake Blvd., Ste. 100, Westlake Village, CA 91362. Specifically check for Lot# 09162015@4 with an expiration date of 10/16/15.
- Brand
Park Compounding Pharmacy- Category
Drug
All 5 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
CA
| Recall number | Product, codes & lots |
|---|---|
| D-0156-2016 | 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; Lot#: 09082015@36, Exp 10/8/15 |
| D-0157-2016 | METHYLCOBALAMIN 1000MCG/ML, 10mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA 91362, (805) 497-8258; Lot#: 09102015@6, Exp 3/8/16 |
| D-0158-2016 | 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; Lot# 09152015@8, Exp, 10/15/15 |
| D-0159-2016 | CAFFEINE + SODIUM BENZOATE 500MG/ML, 35 mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA 91362, (805) 497-8258; Lot# 08062015@27, Exp, 11/4/15 |
| D-0160-2016 | TRI-MIX 20MCG+0.5MG+15MG/ML, 10 mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA 91362, (805) 497-8258; Lot# 09162015@4, Exp, 10/16/15 |
What to do — step by step
Contact the Pharmacy
Call Park Compounding Pharmacy at (805) 497-8258 to inquire about the recall and next steps for your specific prescription.
Check Your Lot Number
Verify if your vial matches Lot# 09162015@4 and expires on or before 10/16/15 to determine if it is part of this recall.
Where it went and when
Where it was distributed
Distributed in California.
FDA distribution: “CA” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California.
Recall timeline
FDA terminated this recall 52 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0160-2016 (October 6, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0160-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 12, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.