The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0681-2017·Announced 2017-05-03

Isomeric Pharmacy Recalls Methylprednisolone Acetate Injection Vials for Sterility Concerns

Isomeric Pharmacy Solution, LLC is recalling 4,001 vials of Methylprednisolone Acetate and Lidocaine HCl injection due to production processes that cannot assure sterility.

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 and involves a lack of assurance of sterility in an injectable product, which poses a significant risk of serious injury or death if contaminated.

Plain-English summary

Isomeric Pharmacy Solution, LLC is recalling 4,001 vials of Methylprednisolone Acetate 40 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For Injection. The recall was initiated because of 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 notice, including lots 09007, 09016, 09020, 09025, 10026, 10030, 11007, 11008, 11020, 11028, and 11043.

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

The recalled product

Product
Methylprednisolone Acetate 40 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1010, barcode 3 70285 10101 4.
Manufacturer
Isomeric Pharmacy Solution, LLC
Category
Drug — Injectable Sterile Product
Hazard
Affected units
4,001

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 (20)

  • Lot #s: 09007
  • Exp 04/04/17
  • 09016
  • Exp 04/16/17
  • 09020
  • Exp 04/18/17
  • 09025
  • Exp 04/23/17
  • 10026
  • 10030
  • Exp 05/28/17
  • 11007
  • Exp 05/30/17
  • 11008
  • Exp 05/31/17
  • 11020
  • Exp 06/07/17
  • 11028
  • Exp 06/12/17
  • 11043

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 →

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