The Recall Desk
SevereFDA (Drugs)·D-1031-2019·Announced 2019-03-27

Advanced Pharma Recalls Heparin Syringes Due to Sterility Concerns

Advanced Pharma Inc. is recalling 1,440 syringes of Heparin 5,000 Units/5mL Injectable Solution nationwide 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, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports, or high-risk contamination.

Plain-English summary

Advanced Pharma Inc. is recalling 1,440 syringes of Heparin 5,000 Units/5mL (1,000 Units per mL) Injectable Solution, 5,000 Units in 0.9% Sodium Chloride, QS 5 mL Sterile single use syringe. The product is identified by NDC 42852-739-67 and Lot 10/25/18 4819 73967S, with an expiration date of 3/24/2019.

The recall was initiated due to a lack of assurance of sterility. The affected units were distributed nationwide.

Consumers and healthcare providers should stop using the recalled product and contact Advanced Pharma Inc. at (877) 794-0404 for further instructions.

The recalled product

Product
Heparin 5,000 Units/5mL (1,000 Units per mL) Injectable Solution, 5,000 Units in 0.9% Sodium Chloride, QS 5 mL Sterile single use syringe, NDC: 42852-739-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
Hazard
Affected units
1,440

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: 10/25/18 4819 73967S Exp. 3/24/2019

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 →