Class III · Low risk
Dexamethasone Sodium Phosphate Injection
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Impurities & degradation products
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present.
704 FDA drug recalls with this cause, newest first.
Every drug has a specification for how much of each impurity or breakdown product it may contain. These recalls are lots that exceeded one of those limits - often a related compound formed during manufacturing or storage, or an out-of-specification result found during routine stability testing. Nitrosamine impurities are common enough to get their own category; everything else lands here.
Class III · Low risk
Dexamethasone Sodium Phosphate Injection
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Class III · Low risk
bupPROPion HCL Extended-Release Tablets
Failed Impurities/Degradation Specifications: Mylan Pharmaceuticals Inc. is conducting a voluntary recall due to related out of specification compound results obtained during routine stability testing.
Class III · Low risk
Lumigan (bimatoprost ophthalmic solution)
Failed Impurities/Degradation Specifications.
Class III · Low risk
Combigan (brimonidine tartrate/timolol maleate ophthalmic solution)
Failed Impurities/Degradation Specifications.
Class II · Moderate risk
Duloxetine Delayed-release Capsules USP
Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.
Class III · Low risk
Famotidine tablets
Failed impurities/degradation specifications: Famotodine has an out of specification result for an individual related substance observed during routine stability testing of a batch for related substances -impurity 8 at 24 month stability interval.
Class II · Moderate risk
Bisoprolol Fumarate tablets
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
Class II · Moderate risk
Glutamine
CGMP Deviations; FDA analysis deterrmined that the product does not contain glutamine and two unknown impurities were observed
Class II · Moderate risk
Alprazolam Tablets
Failed Impurities/Degradation Specifications: Out-of-specification result for an unknown impurity.
Class III · Low risk
Magnesium Citrate Oral Solution Cherry Flavor
Failed Impurities/Degradation Specifications.
Class III · Low risk
Magnesium Citrate Oral Solution Lemon Flavor
Failed Impurities/Degradation Specifications.
Class III · Low risk
ENALAPRIL MALEATE Tablets
Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lot due to out of specification results for related compound.
Class III · Low risk
Enalapril Maleate tablets
Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.
Class III · Low risk
Phentermine Capsules
Failed Impurities/Degradation Specifications:Out of specification results for individual unknown impurities at 30th month Room Temperature Retained Sample stabilities test .
Class III · Low risk
Phentermine HCL Capsules
Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30 month Room Temperature Retained Sample stability test.
Class III · Low risk
Albuterol Sulfate Inhalation Solution
Failed Impurities/Degradation Specifications: high out of specification results for related compound D.
Class II · Moderate risk
Entecavir Tablets 0.5 mg
Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.
Class III · Low risk
Voriconazole Tablets
Failed impurities/degradation specifications: Out of specification for a related compound C.
Class III · Low risk
Deferoxamine Mesylate for injection
CGMP Deviations: Firm failed to control impurity for color change at the API stage.
Class III · Low risk
Pravastatin Sodium Tablets
Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.
Class III · Low risk
Argatroban Injection
Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point
Class III · Low risk
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg 30 tablets per Bottle
Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
Class III · Low risk
Buprenorphine and Naloxone Sublingual Tablets
Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
Class III · Low risk
G & W Clobetasol Propionate Ointment 0.05%
Failed impurities/degradation specifications: This product is being recalled due to out of specification results for Clobetasol Related Compound A, a known impurity which is a degradation product.
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