Why it was recalled
Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)
Product description
Nicardipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL), 10 mL single-use vials, Rx Only, Mfd. by Exela Pharma Sciences, LLC, Lenoir, NC, Dist. by: West-ward Pharmaceutical Corp., Eatontown, NJ --- NDC 0143-9689-10
Lot numbers, UPCs & expiration codes
Lot PLNJ1201 APRIL 2014 Lot PLNJ1202 MAY 2014
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-691-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 13, 2013
- FDA report date
- Jul 17, 2013
- Quantity
- Lot PLNJ1201 -16,880 vials ; Lot PLNJ1202 - 16,960 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- West-ward Pharmaceutical Corp.
Original FDA data
Every field from FDA enforcement report D-691-2013, exactly as published.
Show all FDA fields
- City
- Eatontown
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 65287
- Address
- 465 Industrial Way W
- Code information
- Lot PLNJ1201 APRIL 2014 Lot PLNJ1202 MAY 2014
- Postal code
- 07724-2209
- Report date
- Jul 17, 2013
- Product type
- Drugs
- Recall number
- D-691-2013
- Classification
- Class III
- Recalling firm
- West-ward Pharmaceutical Corp.
- Product quantity
- Lot PLNJ1201 -16,880 vials ; Lot PLNJ1202 - 16,960 vials
- Termination date
- Mar 17, 2015
- Reason for recall
- Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Nicardipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL), 10 mL single-use vials, Rx Only, Mfd. by Exela Pharma Sciences, LLC, Lenoir, NC, Dist. by: West-ward Pharmaceutical Corp., Eatontown, NJ --- NDC 0143-9689-10
- Distribution pattern
- Nationwide
- Recall initiation date
- May 13, 2013
- Initial firm notification
- Letter
- Center classification date
- Jul 11, 2013