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.
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, 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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