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
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.
Lot numbers, UPCs & expiration codes
LOT #201131320087 Exp 09/15
Where it was sold
Nationwide
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-240-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 1, 2013
- FDA report date
- Apr 10, 2013
- Quantity
- 126 injectors
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ferring Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-240-2013, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 64339
- Address
- 4 Gatehall Dr Fl 3rd
- Code information
- LOT #201131320087 Exp 09/15
- Postal code
- 07054-4518
- Report date
- Apr 10, 2013
- Product type
- Drugs
- Recall number
- D-240-2013
- Classification
- Class III
- Recalling firm
- Ferring Pharmaceuticals Inc
- Product quantity
- 126 injectors
- Termination date
- Jul 10, 2013
- 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
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 1, 2013
- Initial firm notification
- Letter
- Center classification date
- Apr 2, 2013