Drug Enforcement D-240-2013

Labeling: Label Mix-up: Units of Lot 201131320087 are packaged in cartons labelled for Needle-Free Head B, but contaiin Needle-Free Head A

Status

Terminated

Classification

Class III

Report Date

April 10, 2013

Termination Date

July 10, 2013

Product Information

Product description
TEV-TROPIN (somatropin (rDNA origin) for injection) 5 mg (15 IU). Prescription Only. Distributed By: TEVA Biologics & Specialty Products Division of Teva Pharmaceuticals USA, Sellersville, PA 18960 Manufactured in Israel.
Product quantity
126 injectors
Reason for recall
Labeling: Label Mix-up: Units of Lot 201131320087 are packaged in cartons labelled for Needle-Free Head B, but contaiin Needle-Free Head A
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Ferring Pharmaceuticals Inc
Address
4 Gatehall Dr Fl 3rd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-240-2013
Event ID
64339
Recall initiation date
February 1, 2013
Center classification date
April 2, 2013
Code info
LOT #201131320087 Exp 09/15
More code info
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