Multi-event February 2018 FDA Recall Hydromorphone Hydrochloride by Pfizer Inc.
This Multi-event Class I drug recall was voluntarily initiated by Pfizer Inc. on February 7, 2018 for the product Hydromorphone Hydrochloride. The FDA reported the reason for recall as non-sterility. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0596-2018
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
02-07-2018
03-21-2018
53600 vials
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Pfizer Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
08-07-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618. NDC: 0703-0110-01
Batch or Lot Expiration Information
Lot# Lots # 691853F, EXP. 9/1/2018; 700753F, EXP. 10/1/2018.
Recall Number: D-0597-2018
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
02-07-2018
03-21-2018
29, 680 vials
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Pfizer Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
08-07-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# Lot 71330DD EXP. 11/1/2018.
