August 2012 FDA Recall Hydromorphone Hydrochloride by Hospira Inc. (D-020-2013 - Superpotent (Single Ingredient) Drug)
This Class I drug recall was voluntarily initiated by Hospira Inc. on August 15, 2012 for the product Hydromorphone Hydrochloride. The FDA reported the reason for recall as superpotent (single ingredient) drug. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-020-2013
Superpotent (Single Ingredient) Drug: The prefilled cartridge unit has been found to be overfilled and contain more than the 1 mL labeled fill volume.
08-15-2012
10-31-2012
216,880 cartridge units
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.
Hospira 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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
05-29-2015
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
HYDROmorphone HCl Injection, USP, 2 mg/mL, 1 mL fill in a 2.5 mL Carpuject prefilled cartridge unit, packaged in 10-count Carpujects per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1312-30, Barcode (01) 1 030409 131230 9 (carton), (01) 0 030409 131230 2 (cartridge unit).
Batch or Lot Expiration Information
Lot# Lot 12720LL, Exp 12/01/13
