Phenylephrine HCl 20 mg recall: CGMP Deviations
Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health 13796 Compark Blvd Englewood CO…
Why was Phenylephrine HCl 20 mg recalled?
CGMP DEVIATIONS
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 #: 2231026, Exp. Date 2/23/2023; 2231051, Exp. Date 3/11/2023; 2231156, Exp. Date 5/29/2023; 2231163, Exp. Date 3/26/2023; 223130, Exp. Date 4 5/7/2023; 2231308, Exp. Date 5/11/2023
- Product
- Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health 13796 Compark Blvd Englewood CO…
- Recalling firm
- Denver Solutions, LLC DBA Leiters Health
- Quantity
- 8,136 units
- Distribution
- Nationwide within the United States including VA or other Government facilities
- Recall date
- March 15, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)