Par Pharmaceutical Recalls Meclizine Hydrochloride Tablets Due to Impurities
Par Pharmaceutical is recalling specific lots of Meclizine Hydrochloride 12.5 mg tablets because they failed impurity specifications.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor specification issues.
Plain-English summary
Par Pharmaceutical Inc. is recalling Meclizine Hydrochloride Tablets, USP, 12.5 mg, in 100-count and 1,000-count bottles. The recall affects specific lots distributed nationwide, including Puerto Rico. The affected products are prescription-only medications.
The recall was initiated because the tablets failed to meet impurities/degradation specifications, meaning they contained out-of-specification impurities. The FDA has classified this as a Class III recall, which indicates that the use of or exposure to the product is not likely to cause adverse health consequences.
Consumers and healthcare providers should stop using the affected lots and return them to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- 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.
- Manufacturer
- Par Pharmaceutical Inc.
- Category
- Drug — Prescription Medication
- Hazard
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 (11)
- a) Lot #: 24820001
- Expiry: NOV 2015
- Lot #: 25783601
- Expiry: OCT 2016
- Lot #: 25783801
- Lot #: 26731201
- Expiry: AUG 2017
- Lot #: 26762002
- Expiry: FEB 2018. b) Lot #: 26683201
- Lot#: 26762001
- Expiry: FEB 2018.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Par Pharmaceutical Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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