The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0685-2017·Announced 2017-05-03

Isomeric Pharmacy Recalls Injection Vials Due to Sterility Concerns

Isomeric Pharmacy Solution, LLC is recalling 851 vials of a multi-dose injection product because production processes 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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable product, which carries a significant risk of serious injury or death if contaminated.

Plain-English summary

Isomeric Pharmacy Solution, LLC is recalling 851 vials of Cyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ Inositol 50 mg/mL/ Choline 50 mg/mL, 30 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 guarantee the sterility of products intended to be sterile. The affected lots are 09003, 11003, 11035, 11039, 12002, and 12012, with expiration dates ranging from April 17, 2017, to July 30, 2017.

Healthcare providers and patients should stop using the affected vials and contact the recalling firm for further instructions. The FDA has classified this as a Class II recall.

The recalled product

Product
Cyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ Inositol 50 mg/mL/ Choline 50 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1101, barcode 3 70285 11013 9.
Manufacturer
Isomeric Pharmacy Solution, LLC
Category
Drug — Injectable
Hazard
Affected units
851

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: 09003
  • Exp 04/17/17
  • 11003
  • Exp 06/21/17
  • 11035
  • Exp 07/03/17
  • 11039
  • Exp 07/05/17
  • 12002
  • Exp 07/23/17
  • 12012
  • Exp 07/30/17.

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 →

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