D-240-2013 Class III Terminated
FDA drug recall D-240-2013 was initiated by Ferring Pharmaceuticals Inc on February 1, 2013 and is designated Class III. 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 The recall status is terminated (terminated July 10, 2013). Affected quantity: 126 injectors.
Recall Details
- Product Type
- Drugs
- Report Date
- April 10, 2013
- Initiation Date
- February 1, 2013
- Termination Date
- July 10, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 126 injectors
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.
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
Distribution Pattern
Nationwide
Code Information
LOT #201131320087 Exp 09/15