FDAClass IMarch 21, 2018

Hydromorphone recall: Sterility Concern

Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Mfd For: Teva Parenteral…

Why was Hydromorphone recalled?

Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.

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 # 691853F, EXP. 9/1/2018; 700753F, EXP. 10/1/2018.

Product
Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Mfd For: Teva Parenteral…
Recalling firm
Pfizer Inc.
Quantity
53600 vials
Distribution
Nationwide in the USA
Recall date
March 21, 2018
Classification
Class I
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls