App Pharmaceuticals Recalls Heparin Lock Flush Solution Due to Documentation Issues
App Pharmaceuticals is recalling specific lots of Heparin Lock Flush Solution because of incomplete documentation associated with test results.
The agency’s classification
FDA (Devices): 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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low severity because it involves documentation issues (incomplete test result records) with no reported illnesses or injuries, fitting the rubric criteria for cosmetic or documentation-only problems.
Plain-English summary
App Pharmaceuticals Llc is voluntarily recalling specific lots of Heparin Lock Flush Solution, USP, 100 USP Units/mL. The affected products are 1 mL and 5 mL multiple dose vials used to maintain the patency of indwelling venipuncture devices. The recall involves Product Code 504501 (Lots 406912 and 408072) and Product Code 504505 (Lot 406914).
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically incomplete documentation associated with test results. The source text does not report any illnesses, injuries, or deaths associated with these products.
The affected products were distributed nationwide and in Puerto Rico. Healthcare providers and patients should stop using the affected lots and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-545-01, Product Code 504501; and HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 5 mL Multiple Dose Vial, 500 USP Units/5 mL, plastic vial, vial size 6 mL…
- Manufacturer
- App Pharmaceuticals Llc
- Hazard
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)
- Product Code 504505 (5 mL): Lot 406914 (Expiration Date 01/12)
Distribution
Part of a larger recall action
This product is one of 2 recalled by App Pharmaceuticals Llc under a single FDA (Devices) 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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See all →- ModerateApp Pharmaceuticals Recalls Heparin Lock Flush Solution Due to Documentation Issues
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