The Recall Desk
SevereFDA (Drugs)·D-1030-2019·Announced 2019-03-27

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.

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. 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
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.

See all 19 products in this recall →