Heparin Injectable Solution Recalled for Incorrect Concentration Labeling
Advanced Pharma Inc. is recalling Heparin Injectable Solution because the label incorrectly states the concentration as 50 mg/50 mL instead of 50 Units/50 mL.
The agency’s classification
FDA (Drugs): 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 2/5 (Moderate).
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, which corresponds to a moderate severity score for minor labeling errors that may cause temporary or medically reversible health consequences.
Plain-English summary
Advanced Pharma Inc. is recalling 160 syringes of HEPERAIN 50 mg/50 mL (1mg/mL) Injectable Solution. The product is a sterile, single-use syringe containing Heparin Sodium in 0.45% Sodium Chloride. The recall was initiated by Avella of Houston, an FDA-registered 503B outsourcing facility located in Houston, Texas.
The recall is due to a labeling error where the product label incorrectly states the concentration as 50 mg/50 mL (1 mg/mL) rather than the accurate concentration of 50 Units/50 mL (1 Unit/mL). This discrepancy in the declared strength could lead to incorrect dosing if the label is relied upon without verification.
The affected product, identified by NDC 42852-725-65, was distributed in Texas and Washington. The specific lot number is 12/19/18 0242 72565S, with a beyond-use date of 3/31/19. Consumers and healthcare providers should stop using the product and contact the recalling firm for further instructions.
The recalled product
- Product
- HEPERAIN 50 mg/50 mL (1mg/mL) Injectable Solution, Heparin Sodium 0.45% Sodium Chloride QS Heparin 50 Units 50 mL, Sterile single use syringe, Avella of Houston an FDA Registered 503B Outsourcing Facility 9265 Kirby Dr. Houston, TX 77054 (877) 794-0404 ---- NDC: 42852-725-65
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Injectable Solution
- Hazard
- Affected units
- 160
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: 12/19/18 0242 72565S BUD: 3/31/19
Distribution
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