NDC 12634-682

Ibuprofen 800 mg tablet

On the label: Apotheca, Inc.. It's repackaged: Apotheca, Inc. rebottles it from Dr.Reddy's Laboratories Ltd.'s NDC 55111-684.

Where the pills inside were made

Repackaging site

• Apotheca Inc., Phoenix, AZ, United States · repackages it and relabels 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

Strength

800 mg

Approval

ANDA ANDA075682

On the market since

Nov 20, 2008

Package NDCs

12634-682-00 12634-682-01 12634-682-09 12634-682-40 12634-682-42 12634-682-50 12634-682-52 12634-682-54 12634-682-57 12634-682-59 12634-682-60 12634-682-61

Official label

DailyMed (National Library of Medicine), updated Jul 6, 2016

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