FDAClass IOctober 31, 2012

HYDROmorphone HCl Injection recall: Superpotent

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).

Why was HYDROmorphone HCl Injection recalled?

Superpotent (Single Ingredient) Drug: The prefilled cartridge unit has been found to be overfilled and contain more than the 1 mL labeled fill volume.

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 12720LL, Exp 12/01/13

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).
Recalling firm
Hospira Inc.
Quantity
216,880 cartridge units
Distribution
Nationwide
Recall date
October 31, 2012
Classification
Class I
Status
Terminated
Agency
FDA (drug)
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