FDAClass IIDecember 21, 2016

Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride recall: Sterility Concern

Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial (1 mg/mL), Single-Dose Injection Solution For Slow IV Use, Rx Only, Cantrell Drug Co.…

Why was Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride recalled?

Lack of Assurance of Sterility - the firm is recalling select sterile drug products.

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: 163941

Product
Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial (1 mg/mL), Single-Dose Injection Solution For Slow IV Use, Rx Only, Cantrell Drug Co.…
Recalling firm
Cantrell Drug Company
Quantity
93 vials
Distribution
Nationwide
Recall date
December 21, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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