The Recall Desk
SevereFDA (Drugs)·D-0158-2016·Announced 2015-11-04

Park Compounding Pharmacy Recalls TRI-MIX Vials Due to Sterility Concerns

Park Compounding Pharmacy is recalling specific lots of TRI-MIX vials because the agency could not ensure the products were sterile.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, and the rubric specifies that FDA Class II recalls involving significant injury or structural defects are Severe; while no injuries are reported, the lack of sterility assurance in a compounded drug is a significant risk.

Plain-English summary

Chen Shwezin, Inc. dba Park Compounding Pharmacy is recalling 2 vials of TRI-MIX 10MCG+0.5MG+15MG/ML, 5 mL vials. The recall is limited to Lot# 09152015@8 with an expiration date of 10/15/15. The product was distributed in California.

The FDA initiated this recall due to a lack of assurance of sterility for all sterile compounded products within their expiry. The source text does not report any specific illnesses or injuries associated with this recall.

Consumers who possess this specific product should contact their healthcare provider or the recalling firm for further instructions on how to proceed.

The recalled product

Product
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
Manufacturer
Chen Shwezin, Inc. dba Park Compounding Pharmacy
Category
Drug — Compounded Sterile Product
Hazard
Affected units
2

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lot# 09152015@8
  • Exp
  • 10/15/15

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 5 recalled by Chen Shwezin, Inc. dba Park Compounding Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Related recalls

Same manufacturer · Chen Shwezin, Inc. dba Park Compounding Pharmacy

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Same hazard · lack of sterility

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