The Recall Desk
HighFDA (Drugs)·D-0684-2017·Announced 2017-05-03

Isomeric Pharmacy Recalls Triamcinolone Diacetate Vials Due to Sterility Concerns

Isomeric Pharmacy Solution, LLC is recalling 1,951 vials of Triamcinolone Diacetate injection because production processes cannot assure sterility. The FDA has classified this as a Class II recall.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The hazard involves a lack of sterility assurance for an injectable product, which poses a risk of infection (a high-risk pathogen scenario) even though no illnesses have been reported. Per the rubric, this falls under 'risk-of-harm products where injury has not yet been reported' or potentially 'high-risk pathogens without reported illness', warranting a score of 3.

Plain-English summary

Isomeric Pharmacy Solution, LLC is voluntarily recalling 1,951 multi-dose vials of Triamcinolone Diacetate 40 mg/mL for injection. The affected products are Rx Only and were distributed nationwide in the USA and Puerto Rico.

The recall was initiated due to a lack of assurance of sterility. Specifically, concerns with production processes mean sterility cannot be assured for these products intended to be sterile.

Affected lots include 10013 (expiration 05/10/17), 10020 (expiration 05/20/17), 10029 (expiration 05/27/17), 11002 (expiration 05/30/17), and 11013 (expiration 06/04/17). The FDA classification for this recall is Class II.

The recalled product

Product
Triamcinolone Diacetate 40 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1021, barcode 3 70285 10211 0.
Manufacturer
Isomeric Pharmacy Solution, LLC
Category
Drug — Injectable Sterile Product
Hazard
Affected units
1,951

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 (10)

  • Lot #s: 10013
  • Exp 05/10/17
  • 10020
  • Exp 05/20/17
  • 10029
  • Exp 05/27/17
  • 11002
  • Exp 05/30/17
  • 11013
  • Exp 06/04/17.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 7 recalled by Isomeric Pharmacy Solution, LLC 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 7 products in this recall →

Related recalls

Same manufacturer · Isomeric Pharmacy Solution, LLC

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Same hazard · non sterile product

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