Class II · Moderate risk
Carvedilol Tablets
Failed Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet thickness.
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
Lac-Hydrin
Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.
Class III · Low risk
Lac-Hydrin
Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.
Class II · Moderate risk
VERSAPHARM Ethambutol Tablets
Discoloration: Ethambutol Tablets USP 400 mg have tablets cores that may be discolored.
Class I · High risk
Carboplatin Injection
Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.
Class I · High risk
Carboplatin Injection
Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.
Class II · Moderate risk
Pradaxa (dabigatran etexilate)
Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product
Class II · Moderate risk
Perphenazine Tablets
Tablet Separation: Possibility of cracked or split coating on the tablets.
Class III · Low risk
CellCept (mycophenolate mofetil)
Short Fill: some bottles contained less than 120-count per labeled claim.
Class II · Moderate risk
Nimodipine Capsules 30 mg
Crystallization: Presence of crystals of Nimodipine within the capsule solution.
Class III · Low risk
Carboplatin Injection
Failed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin API lots which trended out of specification low pH.
Class II · Moderate risk
Metoprolol Tartrate Tablets USP 50 mg
Tablet Thickness: Potential for some tablets not conforming to weight specifications (under and over weight)
Class II · Moderate risk
Octreotide Acetate Injection
Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution.
Class II · Moderate risk
Midazolam HCl Injection
Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution.
Class III · Low risk
Bracco Diagnostics multihance
Short Fill: The product is being recalled due to a potential underfill of the affected vials.
Class II · Moderate risk
Meloxicam Tablets
Tablet Thickness: Recall was initiated due to the presence of one slightly oversized tablet in a bottle of the identified lot.
Class II · Moderate risk
Mefloquine HCL Tablets
Tablet Thickness: Product is being recalled due to the potential of being underweight or overweight.
Class II · Moderate risk
Arthrotec 75
Tablet Separation: The manufacturer of Arthrotec had recalled the lots that were used to re-package this product because they may contain broken tablets.
Class II · Moderate risk
Metronidazole Tablets
Failed Tablet/Capsule Specifications: Some tablets had the potential to not conform to weight specifications.
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