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Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals

Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals Recalls

All product recalls associated with Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals.

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

May 2017

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–20 of 22 recalls

Hydrocortisone Lotion (Qualitest) – Superpotent Drug (2017)

Superpotent Drug: above specification for the assay.

Class IIILow

FDAMay 8, 2017Nationwide• Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals

Dexamethasone Elixir (Qualitest) – Impurity Specifications (2017)

Failed Impurities/ Degradation Specifications

Class IIILow

FDAJan 16, 2017Nationwide• Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals

Temazepam Capsules (Qualitest) – Failed Stability (2016)

Failed Stability Specifications

Class III

Page 1 of 2Next

Low

FDADec 22, 2016Nationwide• Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals

Ranitidine Syrup (Qualitest) – preservative specification (2015)

Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.

Class IIILow

FDAOct 21, 2015Nationwide• Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals

Hydrochlorothiazide Capsules (Qualitest) – Particulate Matter (2015)

Presence of Particulate Matter.

Class IIModerate

FDAOct 7, 2015Nationwide• Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals

Ampicillin Capsules (Qualitest) – Labeling Issue (2015)

Labeling: Incorrect Or Missing Package Insert: Product is labeled with unapproved labeling.

Class IIILow

FDAAug 13, 2015OH• Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals

Lisinopril Tablets 40mg (Qualitest) – Dissolution Failure (2015)

Failed Dissolution Specifications

Class IIModerate

FDAJul 29, 2015Nationwide• Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals

Hydrocodone Acetaminophen (Qualitest) - oversized tablets (2012)

Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets.

Class IHigh

FDADec 6, 2012Nationwide• Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals

Perphenazine Tablets (Qualitest) – Tablet Coating Defect (2012)

Tablet Separation: Possibility of cracked or split coating on the tablets.

Class IIModerate

FDAOct 11, 2012Nationwide• Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals

Hydrocortisone Acetic Acid Otic Solution (Vintage Pharmaceuticals) – impurity risk (2012)

Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point.

Class IIILow

FDAJul 6, 2012Nationwide• Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals

Hydroxyzine Hydrochloride Oral Solution (Vintage Pharmaceuticals) – impurity risk (2012)

Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point.

Class IIILow

FDAJul 6, 2012Nationwide• Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals