Avkare recalls

Avkare appears in 62 official U.S. recall notices indexed by RecallRadar.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

• AvKARE Valsartan and Hydrochlorothiazide 160 mg/25 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc
  FDA Drug · Class II · 2018-09-12 · Avkare
  Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
• Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit Dose Manufactured for: AvKARE, Inc
  FDA Drug · Class II · 2018-09-05 · Avkare
  Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
• Valsartan Tablets, USP 160 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-785-15 Manufactured for: AvKARE, Inc
  FDA Drug · Class II · 2018-09-05 · Avkare
  Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
• Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-784-15 Manufactured for: AvKARE, Inc
  FDA Drug · Class II · 2018-09-05 · Avkare
  Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
• Valsartan Tablets, USP 320 mg Rx Only 30 Tablets (6x5) Unit Dose NDC 50268-786-13 Manufactured for: AvKARE, Inc
  FDA Drug · Class II · 2018-09-05 · Avkare
  Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
• Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only, Manufactured for: AvKARE Inc
  FDA Drug · Class II · 2018-04-25 · Avkare
  Reason: Failed Dissolution Specifications
• Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured for AvKARE, Inc
  FDA Drug · Class II · 2018-01-24 · Avkare
  Reason: Failed Dissolution Specifications: Low out of specification results for dissolution during annual stability testing.
• Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton, unit dose blister UPC 5026828311), Rx only, Manu…
  FDA Drug · Class II · 2017-11-08 · Avkare
  Reason: Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.
• Voriconazole Tablets, 200 mg, 20-count cartons (4 x 5) Unit Dose, Rx only, Manufactured for: AvKARE, Inc
  FDA Drug · Class III · 2017-08-23 · Avkare
  Reason: Failed impurities/degradation specifications: Out of specification for a related compound C.
• Famciclovir tablets, 500 mg, packaged in 30-count unit dose cartons, Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-…
  FDA Drug · Class II · 2017-03-29 · Avkare
  Reason: Failed impurities/ degradation specifications: Product was above specification for unknown impurities.
• Quinapril Tablets USP, 40 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, UPC 502686911…
  FDA Drug · Class III · 2015-03-11 · Avkare
  Reason: Subpotent Drug
• Quinapril Tablets USP, 5 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, UPC 5026868815…
  FDA Drug · Class III · 2015-03-11 · Avkare
  Reason: Subpotent Drug