NDC 71610-078

Rosuvastatin calcium 40 mg tablet, film coated

On the label: Aphena Pharma Solutions - Tennessee, Inc.. It's repackaged: Aphena Pharma Solutions - Tennessee, Inc. rebottles it from Accord Healthcare Inc.'s NDC 16729-287.

Where the pills inside were made

Repackaging site

• Aphena Pharma Solutions - Tennessee, LLC, Cookeville, TN, United States · repackages it

Recalls

• Feb 7, 2023 · Class II · Accord Healthcare, Inc.
  CGMP Deviations: recalling drug products following an FDA inspection.
  Lots: Batches: a) P2101063, Exp. Date 1/31/2024; P2101707, Exp. Date 2/29/2024; P2203913 Exp. Date 6/30/2025; b) P2101064, Exp. Date 1/31/2024; P2101539, Exp. Date 1/31/2024; P2101709, Exp. Date 2/29/2024; P2102138, Exp. Date 2/29/2024; P2103186, Exp. Date 5/31/2024; P2104430, Exp. Date 6/30/2024; P210…
• Feb 7, 2023 · Class II · Accord Healthcare, Inc.
  CGMP Deviations: recalling drug products following an FDA inspection.
  Lots: Batches: a) P2006824, Exp. Date 11/30/2023; P2102223, Exp. Date 3/31/2024; b) P2004949, Exp. Date 8/31/2023; P2004948, Exp. Date 8/31/2023; P2004950, Exp. Date 8/31/2023; P2004953, Exp. Date 8/31/2023; P2004954, Exp. Date 8/31/2023; P2004956, Exp. Date 8/31/2023; P2004955, Exp. Date 8/31/2023; P2…
• Feb 7, 2023 · Class II · Accord Healthcare, Inc.
  CGMP Deviations: recalling drug products following an FDA inspection.
  Lots: Batches: a) P2006560, Exp. Date 11/30/2023; P2101562, Exp. Date 2/28/2024; b) P2006561, Exp. Date 11/30/2023; P2006562, Exp. Date 11/30/2023; P2006587, Exp. Date 11/30/2023; P2100035, Exp. Date 11/30/2023; P2006600, Exp. Date 11/30/2023; P2006603, Exp. Date 11/30/2023; P2006604, Exp. Date 11/30/20…
• Feb 7, 2023 · Class II · Accord Healthcare, Inc.
  CGMP Deviations: recalling drug products following an FDA inspection.
  Lots: Batches: a) P2100343, Exp. Date 12/31/2023; P2102371, Exp. Date 3/31/2024; b) P2101966, Exp. Date 2/28/2024; P2104545, Exp. Date 6/30/2024; P2204500, Exp. Date 7/31/2025; P2205415, Exp. Date 8/31/2025; c) P2101591, Exp. Date 2/28/2023; P2200062, Exp. Date 12/31/2024; P2204336, Exp. Date 7/31/2025…

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

Product details

Generic drug

Rosuvastatin: every company that makes it

Form

tablet, film coated, oral

Strength

40 mg

Approval

ANDA ANDA206434

On the market since

Oct 31, 2016

Package NDCs

71610-078-15 71610-078-45

Official label

DailyMed (National Library of Medicine), updated Jun 30, 2018

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