The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0160-2016·Announced 2015-11-04

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

Park Compounding Pharmacy is recalling 2 vials of TRI-MIX 20MCG+0.5MG+15MG/ML due to a lack of assurance of sterility. The recall affects products distributed in California.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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. According to the rubric, FDA Class II recalls with potential for significant injury or hospitalization (implied by sterility failure in a drug) are rated as Severe.

Plain-English summary

Chen Shwezin, Inc. dba Park Compounding Pharmacy is recalling 2 vials of TRI-MIX 20MCG+0.5MG+15MG/ML, 10 mL vials. The recall is being conducted because of a lack of assurance of sterility for all sterile compounded products within their expiry date.

The affected product is identified by Lot# 09162015@4 and has an expiration date of 10/16/15. The product was distributed in California (CA).

Consumers who have this product should stop using it and contact Park Compounding Pharmacy at (805) 497-8258 for further instructions.

The recalled product

Product
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
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# 09162015@4
  • Exp
  • 10/16/15

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 →

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