App Pharmaceuticals Recalls Heparin Lock Flush Solution Due to Documentation Issues
App Pharmaceuticals is recalling Heparin Lock Flush Solution vials due to incomplete documentation of test results. The recall covers 133,150 vials distributed nationwide and in Puerto Rico.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to CGMP deviations involving incomplete documentation. Per the rubric, this falls under 'Minor labeling errors, low-risk contamination, voluntary precautionary recalls' as there are no reported illnesses or injuries, and the hazard is procedural rather than a direct physical defect causing harm.
Plain-English summary
App Pharmaceuticals Llc is recalling 133,150 vials of Heparin Lock Flush Solution, USP, 10 USP Units/mL, 1 mL Multiple Dose Vial. The product is identified by NDC 63323-544-01 and Product Code 504401. The specific lot affected is Lot 406952, with an expiration date of 02/11.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically incomplete documentation associated with test results. This is a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The affected product was distributed nationwide and in Puerto Rico. Heparin Lock Flush Solution is a prescription-only medication used to maintain the patency of indwelling venipuncture devices designed for intermittent injection or infusion therapy or blood sampling. Consumers and healthcare providers should check their inventory for this specific lot number and discontinue use if found.
The recalled product
- Product
- HEPARIN LOCK FLUSH SOLUTION, USP, 10 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-544-01, Product Code 504401, Rx only To maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood s
- Manufacturer
- App Pharmaceuticals Llc
- Category
- Drug — Injectable Solution
- Hazard
- Affected units
- 133,150
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 406952 (Expiration Date 02/11)
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 →- LowApp Pharmaceuticals Recalls Heparin Lock Flush Solution Due to Documentation Issues
FDA (Devices) · 2012-06-27
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