NDC 53002-2369
Amoxicillin 400 mg per 5 mL powder, for suspension
On the label: RPK Pharmaceuticals, Inc.. It's repackaged: RPK Pharmaceuticals, Inc. rebottles it from Teva Pharmaceuticals USA, Inc.'s NDC 0093-4161.
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.
Repackaging site
- RPK Pharmaceuticals, Inc., Union City, California, United States · relabels it
Recalls
- Jan 26, 2022 · Class II · Cardinal Healthcare
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Lots: Batch 35447184A - Jun 24, 2016 · Class II · Teva North America
Superpotent drug: Out of specification test result for assay during stability testing.
Lots: Lot # 35434158A, Exp 6/17 - Jun 18, 2013 · Class III · Teva Pharmaceuticals USA, Inc.
Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. This is an expansion of RES 65050.
Lots: Lot #s: a) 35426557A, 35426558A, Exp 08/14; b) 35426554A, 35426555A, 35426556A, Exp 08/14 - Apr 26, 2013 · Class III · Teva Pharmaceuticals USA, Inc.
Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the inner foil seal of the bottles.
Lots: a) NDC 0093-4161-78 -- lot numbers 35426081A, 35426082A, 35426083A, 35426084A, Exp: 06/2014; 35426648A, Exp 08/2014; 35427222A, 35427224A, 35427226A, 35427223A, 35427227A, 35427228A, Exp 10/2014; and b) NDC 0093-4161-73 -- lot numbers 35426631A, 35426632A, 35426633A, 35426634A, 35426635A, 3542663…
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Amoxicillin: every company that makes it
- Form
- powder, for suspension
- Strength
- 400 mg per 5 mL
- Approval
- ANDA ANDA065119
- On the market since
- Feb 26, 2003
- Package NDCs
53002-2369-3- Official label
- DailyMed (National Library of Medicine), updated Jun 6, 2023
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