Drug recall: Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle
Failed Dissolution Specifications — Inventia Healthcare Limited · Class II · Ongoing · 11,460 bottles
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Failed Dissolution Specifications — Inventia Healthcare Limited · Class II · Ongoing · 11,460 bottles
Defective container:may contain bottles with incomplete seals — Keystone Industries · Class II · Ongoing · 150 units
CGMP Deviations; deficiencies observed during FDA inspection — Dabur India Limited · Class II · Ongoing · 1102 tubes
CGMP Deviations; deficiencies observed during FDA inspection — Dabur India Limited · Class II · Ongoing · 4,738 tubes
CGMP Deviations; deficiencies observed during FDA inspection — Dabur India Limited · Class II · Ongoing · 4374 tubes
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023 — PAI Holdings LLC · Class II · Ongoing
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023 — PAI Holdings LLC · Class II · Ongoing
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023 — PAI Holdings LLC · Class II · Ongoing
Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg. — Ajanta Pharma USA Inc · Class II · Ongoing · 6,143 bottles
Defective container:may contain bottles with incomplete seals — Keystone Industries · Class II · Ongoing · 150 units
Defective container:may contain bottles with incomplete seals — Keystone Industries · Class II · Ongoing · 450 units
CGMP Deviations; deficiencies observed during FDA inspection — Dabur India Limited · Class II · Ongoing · 1225 tubes
Defective container:may contain bottles with incomplete seals — Keystone Industries · Class II · Ongoing · 150 units
CGMP Deviations; deficiencies observed during FDA inspection — Dabur India Limited · Class II · Ongoing · 5755 tubes
Labeling: Incorrect or Missing Lot and/or Exp Date — Sandoz Inc · Class III · Ongoing · 7,803 bottles
CGMP Deviations; deficiencies observed during FDA inspection — Dabur India Limited · Class II · Ongoing · 8996 tubes
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities. — Glenmark Pharmaceuticals Inc., USA · Class II · Ongoing
CGMP Deviations; deficiencies observed during FDA inspection — Dabur India Limited · Class II · Ongoing · 2420 tubes
Crystallization; identified as Buprenorphine free base — Par Health USA, LLC · Class II · Ongoing · 46,334 units
Defective container:may contain bottles with incomplete seals — Keystone Industries · Class II · Ongoing · 900 units
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023 — PAI Holdings LLC · Class II · Ongoing
CGMP Deviations; deficiencies observed during FDA inspection — Dabur India Limited · Class II · Ongoing · 84 tubes
CGMP Deviations; deficiencies observed during FDA inspection — Dabur India Limited · Class II · Ongoing · 1087 tubes
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification. — Medline Industries, LP · Class II · Ongoing · 4801 units