Advanced Pharma Recalls Heparin Syringes Due to Sterility Concerns
Advanced Pharma Inc. is recalling 500 syringes of Heparin 10 Units/10 mL due to a lack of assurance of sterility. The product was distributed nationwide.
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. According to the rubric, FDA Class II recalls with potential for serious adverse health consequences (such as sterility issues in injectable drugs) are categorized as Severe.
Plain-English summary
Advanced Pharma Inc. is recalling 500 syringes of Heparin 10 Units/10 mL Injectable Solution, Dwell, 10mL Sterile single use syringe (NDC: 42852-725-61). The recall was initiated because of a lack of assurance of sterility. The affected lot is identified by the code 10/23/18 1998 72561SPF with an expiration date of 3/22/2019.
The product was distributed nationwide. The recall is classified as Class II by the U.S. Food and Drug Administration. No specific illnesses or injuries have been reported in the source text.
Consumers and healthcare providers should stop using the affected product and contact Advanced Pharma Inc. at (877) 794-0404 or visit their facility at 9265 Kirby Dr., Houston, TX 77054 for further instructions.
The recalled product
- Product
- Heparin 10 Units/10 mL 10 Units in 0.45% Sodium Chloride, QS 10 mL, Injectable Solution, Dwell, 10mL Sterile single use syringe, NDC: 42852-725-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Injectable Solution
- Hazard
- Affected units
- 500
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 (1)
- Lot: 10/23/18 1998 72561SPF Exp. 3/22/2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 19 recalled by Advanced Pharma Inc. 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.
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