Class II · Moderate risk
Ketorolac Tromethamine Injection
Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.
Other failed specifications
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present.
394 FDA drug recalls with this cause, newest first.
Every drug has a specification sheet: pH, viscosity, moisture, tablet hardness, colour, fill volume, disintegration time. A lot that misses any of them is out of specification, even when the active ingredient is present in the right amount. These recalls include discoloured tablets, crystals forming in a solution, capsules that split, and short-filled containers. They are rarely Class I, but they signal a process that has drifted.
Class III · Low risk
Glipizide Extended-Release Tablets
Failed Moisture Limits: out of specification test results for water content obtained during stability testing.
Class II · Moderate risk
Famotidine USP 20 mg
Failed Tablet/Capsule Specification: out of specification for tablet weight.
Class II · Moderate risk
Famotidine Tablets USP
Failed Tablet/Capsule Specification; out of specification for tablet weight
Class II · Moderate risk
Venlafaxine Hydrochloride Extended-Release Capsules USP
Failed Tablet/Capsules Specifications: pharmacists complaints for bottles containing melted capsules.
Class III · Low risk
BuPROPion HCL Tablets
Failed Moisture Limits: Product tested out-of-specification for moisture content.
Class II · Moderate risk
Oxygen Refrigerated Liquid USP UN 1073
GMP Deviations: The firm does not include an SOP for testing for out of specifications.
Class II · Moderate risk
Buprenorphine HCI Injection
Crystallization: due to the presence of white, crystalline particulates, adhered to the side and bottom of the glass vials, which are comprised of principally dextrose and the buprenorphine active component.
Class III · Low risk
IC-Green (indocyanine green for injection, USP)
Product is being recalled due to low pH value.
Class III · Low risk
Children's Cetirizine Hydrochloride Chewable Tablets
Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.
Class III · Low risk
Doxercalciferol Capsules 0.5mcg
Failed Tablet/Capsule Specifications; during an internal inspection, capsules were found with illegible print.
Class III · Low risk
CLENZIderm M.D. Acne Treatment System
Discoloration.
Class III · Low risk
Class III · Low risk
Montelukast sodium tablets
Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle.
Class III · Low risk
Finasteride Tablets
Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product.
Class II · Moderate risk
Venlafaxine Hydrochloride extended release capsules
Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules.
Class II · Moderate risk
Furosemide Tablets USP
Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.
Class II · Moderate risk
Lisinopril tablets
Failed tablet/capsule specification: missing break line on the 5mg tablet.
Class II · Moderate risk
Temozolomide Capsules
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Class II · Moderate risk
Temozolomide Capsules
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Class II · Moderate risk
Temozolomide Capsules
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Class II · Moderate risk
Temozolomide Capsules
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Class III · Low risk
Pantoprazole Sodium for Injection
Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.
Class II · Moderate risk
10% Premasol sulfite-free
Discoloration: there were customer reports of yellow discolored solution. The yellow coloration is the result of oxidation of the amino acid tryptophan due to a damaged overpouch.
Class II · Moderate risk
Duloxetine Delayed-release Capsules USP 30 mg 30-count bottles
Failed Tablet/Capsule Specifications: Capsule shell (s) opening inside the bottle The Initial reports stated one or two capsules in a bottle count of 30s opening. First report came in June 14, 2016. Till date about 22 reports have come in from pharmacies which report two batches 130/16/001 and 130/16/002. Third batch 130/16/003 is not distributed yet, will be recalled from warehouse.
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