The Recall Desk
SevereFDA (Drugs)·D-0682-2017·Announced 2017-05-03

Isomeric Pharmacy Recalls Methylprednisolone Acetate Injection Vials for Sterility Concerns

Isomeric Pharmacy Solution, LLC is recalling 2,352 vials of Methylprednisolone Acetate 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 classified this as an FDA Class II recall. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While no specific injuries are reported in the text, the lack of sterility assurance in an injectable drug poses a significant risk of serious harm, aligning with the Severe classification for Class II recalls with potential for significant harm.

Plain-English summary

Isomeric Pharmacy Solution, LLC is recalling 2,352 vials of Methylprednisolone Acetate 80 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For Injection. The recall is due to concerns with production processes that cannot assure the sterility of products intended to be sterile.

The affected product is distributed nationwide in the USA and Puerto Rico. Specific lot numbers and expiration dates are listed in the recall documentation, including lots 09022, 10001, 11001, 11010, 11037, and 11041.

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

The recalled product

Product
Methylprednisolone Acetate 80 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 # 1011, barcode 3 70285 10111 3.
Manufacturer
Isomeric Pharmacy Solution, LLC
Category
Drug — Injectable Sterile Product
Hazard
Affected units
2,352

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: 09022
  • Exp 04/22/17
  • 10001
  • Exp 05/02/17
  • 11001
  • Exp 05/31/17
  • 11010
  • Exp 06/03/17
  • 11037
  • Exp 06/19/17
  • 11041
  • Exp 06/25/17.

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 · sterility failure

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