Class III · Low risk Terminated
Equate Beauty Clarifying Face Daily Moisturizer 4 fl. oz.
Reason Failed Stability Specifications
FDA Drug Recalls
1,709 recalls · Class III, newest first
Class III · Low risk Terminated
Magnesium Citrate Oral Solution Cherry Flavor
Reason Failed Impurities/Degradation Specifications.
Class III · Low risk Terminated
Magnesium Citrate Oral Solution Lemon Flavor
Reason Failed Impurities/Degradation Specifications.
Class III · Low risk Terminated
AndroGel
Reason Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Class III · Low risk Terminated
AndroGel
Reason Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Class III · Low risk Terminated
Phentermine
Reason Failed Impurities/Degradation Specification; out-of-specification results for individual unknown impurities at the 30 month Room Temperature Retained Sample stability test
Class III · Low risk Terminated
ENALAPRIL MALEATE Tablets
Reason Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lot due to out of specification results for related compound.
Class III · Low risk Terminated
Enalapril Maleate Tablets
Reason Failed Stability Specifications
Class III · Low risk Terminated
Propafenone Hydrochloride tablets
Reason Failed moisture limits: Out of specification for moisture content.
Class III · Low risk Terminated
Enalapril Maleate tablets
Reason Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.
Class III · Low risk Terminated
Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL
Reason Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance
Class III · Low risk Terminated
Phentermine Capsules
Reason 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 Terminated
Quillivant XR methylphenidate HCl
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Quillivant XR methylphenidate HCl
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Phentermine HCL Capsules
Reason 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 Terminated
Glipizide Extended-Release Tablets
Reason Failed Moisture Limits: out of specification test results for water content obtained during stability testing.
Class III · Low risk Terminated
Albuterol Sulfate Inhalation Solution
Reason Failed Impurities/Degradation Specifications: high out of specification results for related compound D.
Class III · Low risk Terminated
Voriconazole Tablets
Reason Failed impurities/degradation specifications: Out of specification for a related compound C.
Class III · Low risk Terminated
Make Up Perfect terra
Reason Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Class III · Low risk Terminated
Make Up Perfect dark tan
Reason Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Class III · Low risk Terminated
Make Up Perfect sand
Reason Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Class III · Low risk Terminated
Make Up Perfect pastel
Reason Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Class III · Low risk Terminated
Make Up Perfect ivory
Reason Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Class III · Low risk Terminated
Make Up Transparent terra
Reason Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Class III · Low risk Terminated
Make Up Transparent dark tan
Reason Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.