The Recall Desk
SevereFDA (Drugs)·D-0683-2017·Announced 2017-05-03

Isomeric Pharmacy Recalls Triamcinolone Acetonide Injection Vials for Sterility Concerns

Isomeric Pharmacy Solution, LLC is recalling 2,335 vials of Triamcinolone Acetonide and Lidocaine HCl injection due to production processes that cannot assure sterility.

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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable product, which poses a significant risk of serious injury or infection.

Plain-English summary

Isomeric Pharmacy Solution, LLC is recalling 2,335 vials of Triamcinolone Acetonide 40 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For Injection. The product is prescription-only and was distributed nationwide in the USA and Puerto Rico.

The recall was initiated due to a lack of assurance of sterility. The firm identified concerns with production processes that cannot assure the sterility of products intended to be sterile. The affected lots are 09032, 10017, 10022, 10031, 11021, and 12007, with expiration dates ranging from April 2017 to June 2017.

Consumers and healthcare providers should stop using the affected vials and contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product
Triamcinolone Acetonide 40 mg/mL, Lidocaine HCl 10 mg/mL , 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1020, barcode 3 70285 10201 1.
Manufacturer
Isomeric Pharmacy Solution, LLC
Category
Drug — Injectable Sterile Product
Hazard
Affected units
2,335

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 (12)

  • Lot #s: 09032
  • Exp 04/06/17
  • 10017
  • Exp 04/19/17
  • 10022
  • Exp 04/26/17
  • 10031
  • Exp 05/04/17
  • 11021
  • Exp 05/17/17
  • 12007
  • Exp 06/16/17.

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

See all →

Same hazard · sterility failure

See all →