Mylan Recalls Meclizine Hydrochloride Tablets Due to Impurity Failures
Mylan Institutional is recalling 4,609 packages of Meclizine Hydrochloride 25 mg tablets because they failed impurity specifications.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The hazard is a failure in impurity specifications without reported injuries or illnesses.
Plain-English summary
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) is recalling 4,609 packages of Meclizine Hydrochloride Tablets, USP, 25 mg. The product is packaged in 10 x 10 tablet blister packs and is available by prescription only. The specific lot number is 3060153, with an expiration date of 08/31/16.
The recall was initiated because the tablets failed impurities/degradation specifications, specifically being out of specification for impurities. The affected product was distributed nationwide in the United States, including Puerto Rico.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- 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.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 4,609
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 3060153
- Expiry: 08/31/16
Distribution
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