Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Hospira, Inc., Lake forest, IL 60045 USA. NDC: 0409-2634-01
Reported: March 21, 2018 Initiated: February 7, 2018 #D-0597-2018
Product Description
Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Hospira, Inc., Lake forest, IL 60045 USA. NDC: 0409-2634-01
Reason for Recall
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
Details
- Recalling Firm
- Pfizer Inc.
- Units Affected
- 29, 680 vials
- Distribution
- Nationwide in the USA
- Location
- New York, NY
Frequently Asked Questions
What product was recalled? ▼
Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Hospira, Inc., Lake forest, IL 60045 USA. NDC: 0409-2634-01. Recalled by Pfizer Inc.. Units affected: 29, 680 vials.
Why was this product recalled? ▼
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 21, 2018. Severity: Critical. Recall number: D-0597-2018.
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