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.
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 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
- Category
- Drug — Injectable
- 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 →Related recalls
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