Phenylephrine 0.8 mg/10 mL NS recall: Sterility Concern
Phenylephrine 0.8 mg/10 mL NS (0.08 mg/mL), (80 mcg/mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC…
Why was Phenylephrine 0.8 mg/10 mL NS recalled?
Lack of sterility assurance.
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?
Lots: ED041911 Exp. 4/13/2019; ED051910 Exp. 4/14/2019; ED081910 Exp. 4/17/2019; ED091909 Exp. 4/18/2019; ED101910 Exp. 4/19/2019; ED111908 Exp. 4/20/2019
- Product
- Phenylephrine 0.8 mg/10 mL NS (0.08 mg/mL), (80 mcg/mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC…
- Recalling firm
- CMC Enterprise Pharmacy
- Quantity
- 1310 syringes
- Distribution
- NC
- Recall date
- May 1, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)