Why it was recalled
CGMP Deviations: There is potential that Abbott's third party manufacturer, Hospira, may have applied a foreign (incorrect) stopper to vials in a specific lot of Zemplar Injection.
Product description
Zemplar (paricalcitol) Injection, 5 mcg/mL in 2 mL multi-dose vials, 25 vial carton, Rx only, Manufactured by Hospira, Inc. For Abbott Laboratories, North Chicago, IL 60064, USA, NDC 0074-1658-05
Lot numbers, UPCs & expiration codes
Lot #: 11-122-DK, Exp 10/13
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-1388-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 14, 2012
- FDA report date
- Jun 27, 2012
- Quantity
- 121,000 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Abbott Laboratories
Original FDA data
Every field from FDA enforcement report D-1388-2012, exactly as published.
Show all FDA fields
- City
- Abbott Park
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 61878
- Address
- 100 Abbott Park Rd
- Code information
- Lot #: 11-122-DK, Exp 10/13
- Postal code
- 60064-3502
- Report date
- Jun 27, 2012
- Product type
- Drugs
- Recall number
- D-1388-2012
- Classification
- Class II
- Recalling firm
- Abbott Laboratories
- Product quantity
- 121,000 vials
- Termination date
- Dec 3, 2012
- Reason for recall
- CGMP Deviations: There is potential that Abbott's third party manufacturer, Hospira, may have applied a foreign (incorrect) stopper to vials in a specific lot of Zemplar Injection.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Zemplar (paricalcitol) Injection, 5 mcg/mL in 2 mL multi-dose vials, 25 vial carton, Rx only, Manufactured by Hospira, Inc. For Abbott Laboratories, North Chicago, IL 60064, USA, NDC 0074-1658-05
- Distribution pattern
- Nationwide
- Recall initiation date
- May 14, 2012
- Initial firm notification
- Letter
- Center classification date
- Jun 18, 2012