Heperain 50 Mg/50 Ml recall: Labeling Error
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…
Why was Heperain 50 Mg/50 Ml recalled?
Labeling; Label Error on Declared Strength; label incorrectly states the concentration as 50 mg/50 mL (1 mg/mL) rather than the fully accurate concentration as 50 Units/50 mL (1 Unit/mL)
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: 12/19/18 0242 72565S BUD: 3/31/19
- 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…
- Recalling firm
- Advanced Pharma Inc.
- Quantity
- 160 syringes
- Distribution
- TX, WA
- Recall date
- January 30, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)