Heparin Injection Recalled Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling heparin injectable solutions nationwide due to sterility concerns identified during an FDA inspection. Over 11,000 bags of the product are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall without reported illnesses or confirmed contamination. However, heparin is a high-risk injectable medication where loss of sterility assurance could result in serious infection. Per the rubric, risk-of-harm products without reported injury score as High (3).
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling approximately 11,117 bags of heparin added to 0.9% sodium chloride injection (4 units/mL, 1,000 mL per bag). The product, distributed nationwide in the United States, is identified by NDC 71285-7022-1 and includes multiple lot numbers with expiration dates between May 2 and May 30, 2023.
An FDA inspection determined that the sterility of these products could not be assured. For injectable solutions intended to be sterile, loss of sterility assurance represents a potential risk of serious infection if the product is administered to patients.
Patients who have received this product should consult their healthcare provider if they have concerns about their treatment. Healthcare facilities and pharmacies should immediately stop distributing the affected lots and quarantine all inventory. Specific lot numbers are listed in the FDA recall notice. Questions should be directed to the recalling firm.
The recalled product
- Product
- heparin added to 0.9% sodium chloride, 4,000 units/1,000 mL* (4 units/mL), 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7022-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Hazard
- sterility-loss
- infection-risk
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 (20)
- Lot # 37-888633
- 37-888637
- 37-888641
- 37-888658
- 37-888666
- 37-888839
- Exp 05/02/2023
- 37-890332
- 37-890383
- 37-890394
- 37-890424
- 37-890428
- 37-890442
- Exp 05/09/2023
- 37-892010
- 37-892021
- 37-892046
- 37-892061
- 37-892116
- 37-892120
Distribution
Distributed nationwide across the United States.
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