NDC 71205-635

Quinapril 10 mg tablet

On the label: Proficient Rx LP. It's repackaged: Proficient Rx LP rebottles it from Lupin Pharmaceuticals, Inc.'s NDC 68180-557.

Where the pills inside were made

Repackaging site

• Proficient Rx LP, Thousand Oaks, CA, United States · repackages it and relabels it

Recalls

• Dec 7, 2022 · Class II · Lupin Pharmaceuticals Inc.
  CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
  Lots: Lot #: G100533, G100534, Exp. 12/2022; G203071, Exp. 03/2024
• Dec 7, 2022 · Class II · Lupin Pharmaceuticals Inc.
  CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
  Lots: Lot #: G102929, Exp 04/2023
• Dec 7, 2015 · Class III · Lupin Pharmaceuticals Inc.
  Failed Impurities/Degradation Specifications; Impurity A
  Lots: Batch number G303703, exp 3/2016
• Sep 17, 2013 · Class II · Lupin Pharmaceuticals Inc.
  Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval
  Lots: Lots 3104879, 3104880, Exp. 10/13, 3110218, 3110219, 3110220 Exp. 12/13
• Sep 17, 2013 · Class II · Lupin Pharmaceuticals Inc.
  Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval
  Lots: Lot 3110358 Exp. 12/13

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.

Product details

Generic drug

Quinaprilat: every company that makes it

Form

tablet, oral

Strength

10 mg

Approval

ANDA ANDA077690

On the market since

Feb 26, 2007

Package NDCs

71205-635-30 71205-635-60 71205-635-90

Official label

DailyMed (National Library of Medicine), updated May 1, 2022

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