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.
Product description
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
PA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1385-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 28, 2014
- FDA report date
- Jun 25, 2014
- Quantity
- 129,060 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ferring Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-1385-2014, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 68407
- Address
- 4 Gatehall Dr Fl 3rd
- Code information
- 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
- Postal code
- 07054-4518
- Report date
- Jun 25, 2014
- Product type
- Drugs
- Recall number
- D-1385-2014
- Classification
- Class II
- Recalling firm
- Ferring Pharmaceuticals Inc
- Product quantity
- 129,060 cartons
- Termination date
- Aug 6, 2015
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- PA
- Recall initiation date
- Apr 28, 2014
- Initial firm notification
- Letter
- Center classification date
- Jun 17, 2014