NDC 43353-314
Ibuprofen 600 mg tablet, film coated
On the label: Aphena Pharma Solutions - Tennessee, Inc.. It's repackaged: Aphena Pharma Solutions - Tennessee, Inc. rebottles it from Dr.Reddy's Laboratories Ltd.'s NDC 55111-683.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Dr. Reddy's Laboratories Limited | Medchal-Malkajgiri, India | Makes it and tests it | Problems found, fixed voluntarilyOct 27, 2023 · 8 inspections |
Repackaging site
- Aphena Pharma Solutions - Tennessee, LLC, Cookeville, TN, United States · repackages it
Recalls
- Oct 29, 2024 · Class III · Dr. Reddy's Laboratories, Inc.
Failed Tablet/Capsule Specifications
Lots: Lot #: C5406201, Exp 03/31/2028 - Aug 6, 2024 · Class II · Dr. Reddy's Laboratories, Inc.
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Lots: a) NDC 55111-684-01 Lots C2207525, Exp 5/31/2026; C2212902, Exp 11/30/2026. b) NDC 55111-684-05 Lots C2207526, Exp 5/31/2026; C2210751, C2210752, Exp 9/30/2026; C2212765, C2212766, Exp 11/30/2026; C2301027, C2301063, C2301187, C2301188, C2301247, Exp 12/31/2026; C2301356, C2301388, C2301494, C23… - Aug 6, 2024 · Class II · Dr. Reddy's Laboratories, Inc.
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Lots: a)NDC 55111-683-01 Lots C2207527, Exp 5/31/2026; C2210864, Exp 9/30/2026; C2213018, Exp 11/30/2026. b)NDC 5511-683-05 Lots C2207528, Exp 5/31/2026; C2210860, Exp 9/30/2026; C2213016, C2213017, Exp 11/30/2026; C2301852, C2302056, C2302057, Exp 1/31/2027. - Aug 6, 2024 · Class II · Dr. Reddy's Laboratories, Inc.
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Lots: a)NDC 55111-682-01 Lots C2207529, Exp 5/31/2026; C2210993, Exp 9/30/2026. b)NDC 55111-682-05 Lots C2207530, Exp 5/31/2026; C2210992, C2210994, Exp 9/30/2026; C2213304, C2213305, Exp 11/30/2026. - Aug 29, 2013 · Class II · Dr. Reddy's Laboratories, Inc.
Labeling: Incorrect or missing lot and/or exp date- This product is being recalled due to an incorrect expiration date of 05/2017. The correct expiration date is 10/2016.
Lots: Lot # L300192; Exp. 05/2017
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Ibuprofen: every company that makes it
- Form
- tablet, film coated
- Strength
- 600 mg
- Approval
- ANDA ANDA075682
- On the market since
- Jun 10, 2009
- Package NDCs
43353-314-6043353-314-8043353-314-92- Official label
- DailyMed (National Library of Medicine), updated Dec 17, 2019
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