Recalls / Class III
Class IIID-240-2013
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.
- Affected lot / code info
- LOT #201131320087 Exp 09/15
Why it was recalled
Labeling: Label Mix-up: Units of Lot 201131320087 are packaged in cartons labelled for Needle-Free Head B, but contaiin Needle-Free Head A
Recalling firm
- Firm
- Ferring Pharmaceuticals Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4 Gatehall Dr Fl 3rd, N/A, Parsippany, New Jersey 07054-4518
Distribution
- Quantity
- 126 injectors
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-02-01
- FDA classified
- 2013-04-02
- Posted by FDA
- 2013-04-10
- Terminated
- 2013-07-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-240-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.