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.
Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.
Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.
Failed pH specification: Product pH test value of 5.72 failed to meet its product specification of 6.0 to 7.5.
Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules.
Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
Discoloration: Reconstituted solution may appear pink instead of colorless to pale yellow when stored per the labeled conditions.
Failed Tablet/Capsule Specifications: Complaints of empty capsules received.
Crystallization: Impurities in a raw material used to manufacture the diluent can cause the formation of crystals in the diluent vials after cold storage. The TORISEL vials are not affected by this issue.
Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344.
Crystallization: Formation of crystals observed in product.
Failed Tablet/Capsule Specifications: Presence of split or broken tablets.
Failed Tablet/Capsule Specifications: Broken tablets found in sealed bottles.
Failed pH Specification: A pH result of 2.9 was obtained at the 9 month stability test interval at 25C/60%RH. The registered specification for pH is 3.0 - 7.0
Failed Tablet/Capsule Specifications: Ink identification had rubbed off tablets in transit making them illegible to pharmacists and consumers.
Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Failed Tablet/Capsule Specifications: Teva is recalling one lot of Carbidopa and Levodopa Tablets USP, 25mg/100mg due to the potential for superpotent tablets.
Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Fluvastatin Capsules USP, 20 mg due to a customer complaint trend regarding capsule breakage.
Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution
Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution
Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
Presence of Precipitate: Small amounts of diphenydramine and mannitol precipitated out of solution.
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles.
Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.
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