The Recall Desk
SevereFDA (Drugs)·D-1029-2013·Announced 2013-09-18

Pharmacy Creations Recalls EDTA Disodium Injection Due to Sterility Concerns

Pharmacy Creations is recalling EDTA disodium 150 mg/mL sterile injection vials due to a lack of assurance of 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 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 infection or serious injury.

Plain-English summary

Pharmacy Creations is recalling EDTA disodium 150 mg/mL sterile injection, 20 mL multi-dose vials. The recall is being conducted due to a lack of assurance of sterility.

The affected product is identified by Lot # 070213Z with an expiration date of 1/2/2014. The recall involves 75 vials that were distributed in New Jersey.

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

The recalled product

Product
EDTA disodium 150 mg/mL Sterile Injection, 20 mL Multi Dose Vial, Pharmacy Creations, Randolph, NJ 07869
Manufacturer
Pharmacy Creations
Affected units
75

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 (2)

  • Lot # 070213Z
  • Exp 1/2/2014

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 2 recalled by Pharmacy Creations 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 2 products in this recall →