NDC 42291-905

Pitavastatin 1.045 mg tablet, film coated

On the label: AvKARE, Inc.. It's repackaged: AvKARE, Inc. rebottles it from Teva Pharmaceuticals, Inc.'s NDC 0480-3631.

Where the pills inside were made

Recalls

• Jun 26, 2025 · Class III · AvKARE
  Failed Impurity/Degradation Specifications
  Lots: Lot, expiry: Lot 46208, exp 10/31/2025; Lot 47738, exp 09/30/2026; Lot 46943, exp 05/31/2026;
• Jun 26, 2025 · Class III · AvKARE
  Failed Impurity/Degradation Specifications
  Lots: Lot, expiry: Lot 46211, exp 10/31/2025; Lot 47683, exp 05/31/2026; Lot 46944 , exp 01/31/2026
• Jun 11, 2025 · Class III · Orient Pharma Co., Ltd. Yunlin Plant
  Failed Impurities/Degradation Specifications.
  Lots: P061001, P061002, P061003, P061004, P061006 & P061007 Exp Date 07/2025; P061008, Exp Date 08/2025; P061009 & P061010 Exp Date 10/2025; P061011, P061012 & P061013 Exp Date 01/2026; P061016, P061017 & P061018, Exp Date 04/2026; P061019, Exp Date 05/2026; P061023, Exp Date 01/2027.
• Jun 11, 2025 · Class III · Orient Pharma Co., Ltd. Yunlin Plant
  Failed Impurities/Degradation Specifications.
  Lots: P051001, P051002, & P051003, Exp Date 07/2025; P051005, Exp Date 10/2025; P051006, Exp Date 10/2025; P051007, Exp Date 01/2026; P051010, Exp Date 07/2026; P051011 & P051012, Exp Date 09/2026; P051013, P051014 and P051015, Exp Date 01/2027.

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

Product details

Generic drug

Pitavastatin: every company that makes it

Form

tablet, film coated, oral

Strength

1.045 mg

Approval

ANDA ANDA205932

On the market since

Jan 16, 2024

Package NDCs

42291-905-90

Official label

DailyMed (National Library of Medicine), updated Jan 16, 2026

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