NDC 10544-522
Clarithromycin 500 mg tablet, film coated
On the label: Blenheim Pharmacal, Inc.. It's repackaged from NDC 64679-949, made by Wockhardt USA LLC. (Clarithromycin). That product's FDA listing has since ended, so its label and factories are no longer published.
Where the pills inside were made
This label doesn't name the factory that makes the drug (it lists 1 site that repackages it). 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 Blenheim Pharmacal, Inc. names for other drugs.
Recalls
- May 22, 2015 · Class II · Blenheim Pharmacal, Inc.
cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wockhardt Limited, following a FDA inspection which noted inadequate investigation of market complaints, resulting in unsuccessful identification of root causes, and the investigation not being expanded to prevent repeat failure
Lots: Lot BP18181301, Exp. Date 02/29/2016
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Clarithromycin: every company that makes it
- Form
- tablet, film coated
- Strength
- 500 mg
- Approval
- ANDA ANDA065266
- On the market since
- Oct 5, 2012
- Package NDCs
10544-522-1410544-522-20- Official label
- DailyMed (National Library of Medicine), updated Dec 31, 2015
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?