Recalls / Class II
Class IID-1385-2014
Product
TEV-TROPIN [somatropin (rDNA origin) for injection] 5 mg (15 IU) 1-count bottle, Rx Only, Manufactured in Israel, Distributed by: Gate Pharmaceuticals div. of Teva Pharmaceuticals USA Sellersville,PA 18960. NDC 57844-713-46
- Affected lot / code info
- Lot # H11599A; Exp. 03/16 Lot # H11599B; Exp. 03/16 Lot # H12913A; Exp. 05/16 Lot # H12913B; Exp. 05/16 Lot # H12914A; Exp. 05/16 Lot # H12914B; Exp. 05/16 Lot # H13846A; Exp. 07/16 Lot # H13846B; Exp. 07/16
Why it was recalled
Chemical Contamination: TEV-TROPIN [somatropin (rDNA origin) for injection] may contain silicone oil due to leakage of a leaking line during the freeze-drying process.
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
- 129,060 cartons
- Distribution pattern
- PA
Timeline
- Recall initiated
- 2014-04-28
- FDA classified
- 2014-06-17
- Posted by FDA
- 2014-06-25
- Terminated
- 2015-08-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1385-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.