FDAClass IIOctober 19, 2016

labetalol HCl recall

labetalol HCl, 5 mg per mL, 20 mg per 4 mL, 4 mL total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3117.

Why was labetalol HCl recalled?

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

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 Numbers: 15112079M, 15112124M, Exp between 07/15/15-10/12/15

Product
labetalol HCl, 5 mg per mL, 20 mg per 4 mL, 4 mL total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3117.
Recalling firm
Pharmedium Services, LLC
Quantity
969 syringes
Distribution
Nationwide
Recall date
October 19, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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