Why it was recalled
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
Product description
PARICALCITOL Capsules, 4 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7658-56.
Lot numbers, UPCs & expiration codes
Lot #: 13010.006A, Exp 09/16; 13010.007A, Exp 05/17
Where it was sold
Nationwide and Puerto Rico
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-0111-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 22, 2016
- FDA report date
- Oct 26, 2016
- Quantity
- 5,398 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0111-2017, exactly as published.
Show all FDA fields
- City
- North Wales
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 75300
- Address
- 1090 Horsham Rd
- Code information
- Lot #: 13010.006A, Exp 09/16; 13010.007A, Exp 05/17
- Postal code
- 19454-1505
- Report date
- Oct 26, 2016
- Product type
- Drugs
- Recall number
- D-0111-2017
- Classification
- Class III
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 5,398 bottles
- Termination date
- May 5, 2017
- Reason for recall
- Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- PARICALCITOL Capsules, 4 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7658-56.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Sep 22, 2016
- Initial firm notification
- Letter
- Center classification date
- Oct 19, 2016