Drug product
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.
D-240-2013
Product summary
- Event
- Event 64339
- Status
- Terminated
- Classification
- Class III
- Quantity
- 126 injectors
- Official record key
drug-enforcement:D-240-2013
Official wording
Reason: Labeling: Label Mix-up: Units of Lot 201131320087 are packaged in cartons labelled for Needle-Free Head B, but contaiin Needle-Free Head A
Code information: LOT #201131320087 Exp 09/15
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Label Mix-up