Recall Enforment Report D-0234-2016
Recall Details
Multi event Drug Recall Enforcement Report Class III voluntary initiated by Par Pharmaceutical Inc., originally initiated on 10-26-2015 for the product Meclizine Hydrochloride Tablets USP, 25 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-035-01) and b) 1000 Ct Bottles (NDC: 49884-035-10), Rx only. Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977. The product was recalled due to failed impurities/degradation specifications: out of specification for impurities.. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|---|
| D-0234-2016 | 10-26-2015 | 11-25-2015 | Class III | a) 387,100 Bottles; b) 63,572 Bottles | Meclizine Hydrochloride Tablets USP, 25 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-035-01) and b) 1000 Ct Bottles (NDC: 49884-035-10), Rx only. Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977. | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Terminated |
| D-0233-2016 | 10-26-2015 | 11-25-2015 | Class III | a) 162,385 Bottles; b) 6949 Bottles | Meclizine Hydrochloride Tablets, USP, 12.5 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-034-01) and b) 1000 Ct Bottles (NDC: 49884-034-10), Rx only. Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977. | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Terminated |
