Meclizine Hydrochloride Tablets recall: Impurity Out of Spec
Meclizine Hydrochloride Tablets, USP, 25 mg Tablets, Packaged in 10 x 10 Tablet Blister Pack Packages, Rx Only. Manufactured by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977. Mylan. NDC: 51079-090-20.
Why was Meclizine Hydrochloride Tablets recalled?
Failed Impurities/Degradation Specifications: Out of specification for impurities.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 3060153, Expiry: 08/31/16
- Product
- Meclizine Hydrochloride Tablets, USP, 25 mg Tablets, Packaged in 10 x 10 Tablet Blister Pack Packages, Rx Only. Manufactured by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977. Mylan. NDC: 51079-090-20.
- Recalling firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Quantity
- 4,609 Packages
- Distribution
- US Nationwide including Puerto Rico
- Recall date
- November 25, 2015
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)