NORepiNEPHrine 8 mg recall: Sterility Concern
NORepiNEPHrine 8 mg (norepinephrine Bitartrate (USP) 8 mg added to 5% Dextrose Inj. (USP) 250 mL. (Concentration 32 mcg/mL) Volume: 258 mL. Single…
Why was NORepiNEPHrine 8 mg recalled?
Lack of Assurance of Sterility: Potential leakage of bags.
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 #4/23/18 0101 81525P, 4/23/18 1020 81525P, BUD 6/22/2018;4/30/18 1123 81525P, 4/30/18 1311 81525P, BUD 6/29/2018; 5/1/18 3456 81525P, BUD 6/30/2018; 5/8/18 3213 81525P, BUD 7/7/2018.
- Product
- NORepiNEPHrine 8 mg (norepinephrine Bitartrate (USP) 8 mg added to 5% Dextrose Inj. (USP) 250 mL. (Concentration 32 mcg/mL) Volume: 258 mL. Single…
- Recalling firm
- Avella of Deer Valley, Inc. Store 38
- Quantity
- 4,280 bags
- Distribution
- Nationwide in the USA
- Recall date
- July 25, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)