Why it was recalled
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Product description
Natpara (parathyroid hormone) for Injection, 50 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0203-02
Lot numbers, UPCs & expiration codes
06628461, exp 8/31/2020 06661658, 07110136, 7164106, 07761970 exp 10/31/2020 07630717, 08689119, exp 12/31/2020 07769458, exp 4/30/2021 07983643, 08003758, exp 6/30/2021 08214790, exp 8/31/2020 NY17002DA, NY17002DB, exp 6/30/2020
Where it was sold
Product was distributed throughout the United States.
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-0036-2020
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Sep 12, 2019
- FDA report date
- Oct 2, 2019
- Quantity
- 13,897
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Shire Human Genetic Therapies, Inc.
Original FDA data
Every field from FDA enforcement report D-0036-2020, exactly as published.
Show all FDA fields
- City
- Lexington
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 83792
- Address
- 300 Shire Way
- Code information
- 06628461, exp 8/31/2020 06661658, 07110136, 7164106, 07761970 exp 10/31/2020 07630717, 08689119, exp 12/31/2020 07769458, exp 4/30/2021 07983643, 08003758, exp 6/30/2021 08214790, exp 8/31/2020 NY17002DA, NY17002DB, exp 6/30/2020
- Postal code
- 02421-2101
- Report date
- Oct 2, 2019
- Product type
- Drugs
- Recall number
- D-0036-2020
- Classification
- Class I
- Recalling firm
- Shire Human Genetic Therapies, Inc.
- Product quantity
- 13,897
- Termination date
- Mar 23, 2021
- Reason for recall
- Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Natpara (parathyroid hormone) for Injection, 50 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0203-02
- Distribution pattern
- Product was distributed throughout the United States.
- Recall initiation date
- Sep 12, 2019
- Initial firm notification
- Letter
- Center classification date
- Oct 1, 2019