Class II · Moderate risk
Meclizine Hydrochloride Tablets
Failed tablet specifications.
Meclizine Hydrochloride Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
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.
Affected NDCs
49884-0034-01
49884-0034-10
Compare with the code on your package — it is the most precise check available.
Drug: Meclizine
- Recalling firm
- Par Pharmaceutical Inc.
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0233-2016 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Meclizine recalls
See all
Class II · Moderate risk
Meclizine Hydrochloride Tablets
cGMP deviations: Temperature abuse
Class I · High risk
Meclizine Hydrochloride Tablets USP
Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydrochloride Tablets contain bottles incorrectly labeled as PredniSONE Tablets. The tablets in the bottles are Meclizine Hydrochloride
Class II · Moderate risk
Meclizine HCl Tablets
Labeling: Incorrect Instructions
Class II · Moderate risk
Meclizine HCl Tablets
Failed Dissolution Specifications
Other recalls by Par Pharmaceutical Inc.
All 2015 recalls
Class II · Moderate risk
BusPIRone Hydrochloride Tablets
Failed Impurity /Degradation Specifications
Class II · Moderate risk
Glycopyrrolate Tablets
Failed Impurities/Degradation Specification: Presence of unknown impurity observed.
Class III · Low risk
PrediniSONE Tablets
Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg
Class III · Low risk
Frovatriptan Succinate Tablets
Labeling: Incorrect or Missing Lot and/or Exp Date: Product incorrectly labeled with an expiration date of August 2022 rather than the correct expiration date of April 2022.
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