NDC 52959-433
Hydroxyzine Pamoate 25 mg capsule
On the label: H.J. Harkins Co., Inc.. It's repackaged: H.J. Harkins Co., Inc. rebottles it from Teva Pharmaceuticals USA, Inc.'s NDC 0555-0323.
Where the pills inside were made
This label doesn't name the factory that makes the drug. Companies don't have to print it on the label. The maker's name is often on the stock bottle your pharmacy used; you can ask the pharmacist. See the plants Teva Pharmaceuticals USA, Inc. names for other drugs.
Recalls
- Jan 24, 2014 · Class II · Teva Pharmaceuticals USA
CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 100 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing.
Lots: Lot # 34017426A, Exp. 10/16. - Jan 24, 2014 · Class II · Teva Pharmaceuticals USA
CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 25 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing.
Lots: Lot # 34016752A, Exp. 09/16. Lot # 34016753A, Exp. 09/16.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Hydroxyzine: every company that makes it
- Form
- capsule
- Strength
- 25 mg
- Approval
- ANDA ANDA088496
- On the market since
- Jul 1, 2010
- Package NDCs
52959-433-1052959-433-1552959-433-2052959-433-3052959-433-4052959-433-5052959-433-60- Official label
- DailyMed (National Library of Medicine), updated Apr 19, 2012
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