Vintage Pharmaceuticals recalls
Vintage Pharmaceuticals appears in 12 official U.S. recall notices indexed by RecallRadar, most recently on 2017-05-31.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 12 |
|---|---|
| Published | 2012-07-18 to 2017-05-31 |
| By agency | FDA Drug (12) |
| By classification | Class III (7), Class II (3), Class I (2) |
| By status | terminated (11), ongoing (1) |
| Distribution named in notices | OH, US |
Recalls
- HYDROCORTISONE LOTION, USP, 2.5%, 2 FL OZ (59 mL) bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0…
FDA Drug · Class III · 2017-05-31 · Vintage Pharmaceuticals
Reason: Superpotent Drug: above specification for the assay. - DEXAMETHASONE ELIXIR, USP, 0.5 mg/5 mL, 8 fl.oz., Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL, NDC 0603-1147-56
FDA Drug · Class III · 2017-02-01 · Vintage Pharmaceuticals
Reason: Failed Impurities/ Degradation Specifications - TEMAZEPAM CAPSULES USP, 7.5 mg, 100 count bottles, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-589…
FDA Drug · Class III · 2017-01-11 · Vintage Pharmaceuticals
Reason: Failed Stability Specifications - HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 3000 count bottles, Rx only, Manufactured for: Qualitest Pharmaceuticals, Inc., Huntsville, AL…
FDA Drug · Class II · 2015-11-25 · Vintage Pharmaceuticals
Reason: Presence of Particulate Matter. - RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 mL (16 fl oz), Rx only
FDA Drug · Class III · 2015-11-11 · Vintage Pharmaceuticals
Reason: Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben. - Lisinopril Tablets, USP, 40 mg, a) 45-count bottle (NDC 0603-4214-60), b) 500-count bottle (NDC 0603-4214-28), Rx Only, Manufactured for: Q…
FDA Drug · Class II · 2015-09-09 · Vintage Pharmaceuticals
Reason: Failed Dissolution Specifications - AMPICILLIN CAPSULES, USP, 250 mg, 500 count bottles, Rx only, Manufactured for: DAVA Pharmaceuticals, Inc., Fort Lee, NJ, By: Suir Pharma I…
FDA Drug · Class III · 2015-08-26 · Vintage Pharmaceuticals
Reason: Labeling: Incorrect Or Missing Package Insert: Product is labeled with unapproved labeling. - Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg, packaged in a) 30-count bottles, NDC 0603-3888-16
FDA Drug · Class I · 2013-02-06 · Vintage Pharmaceuticals
Reason: Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets. - HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSV…
FDA Drug · Class I · 2012-11-28 · Vintage Pharmaceuticals
Reason: Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components. - Perphenazine Tablets, USP, 8 mg, 100-count tablets per bottle, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-…
FDA Drug · Class II · 2012-10-31 · Vintage Pharmaceuticals
Reason: Tablet Separation: Possibility of cracked or split coating on the tablets. - HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP, 10 mg/5 mL, 1 PINT (473 mL) bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE,…
FDA Drug · Class III · 2012-07-25 · Vintage Pharmaceuticals
Reason: Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point. - HYDROCORTISONE and ACETIC ACID OTIC SOLUTION, USP, 10 mL bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811
FDA Drug · Class III · 2012-07-18 · Vintage Pharmaceuticals
Reason: Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point.