Food, drugs, devices › Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals

Drug recall: Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg, packaged in a) 30-count bottles, NDC 0603-3888-16;

FDA enforcement event 63818 · Class I · initiated 6 Dec 2012 · status Terminated · terminated 20 Jul 2021

DrugVoluntary: Firm initiated1 product recordHuntsville, AL

FDA enforcement event 63818 is a drug recall by Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals of Huntsville, AL, initiated 6 Dec 2012 and classified Class I, with 1 product record.

FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 15% of the 209 drug enforcement events initiated in 2012 carry the same class.

Status: Terminated, terminated 20 Jul 2021. Initiation: voluntary: firm initiated. Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals has 12 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals, Huntsville, AL.

Reason for recall

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

Distribution

"Nationwide and Puerto Rico"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-138-2013	Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg, packaged in a) 30-count bottles, NDC 0603-3888-16; b) 60-count bottles, NDC 0603-3888-20; c) 90-count bottles, NDC 0603-3888-02; d) 100-count bottles, NDC 0603-3888-21; e) 120-count bottles, NDC 0603-3888-22; f) 150-count bottles, NDC 0603-3888-26;…	897,379 bottles	Class I	Terminated	6 Feb 2013

Context

15%of 2012 drug events are Class I209 events that year

1product record in this eventfirm median: 1

12events on this register for the firm

Other enforcement events for Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals

Initiated	Product (first record)	Type	Class	Records
8 May 2017	HYDROCORTISONE LOTION, USP, 2.5%, 2 FL OZ (59 mL) bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVIL	Drug	Class III	1
16 Jan 2017	DEXAMETHASONE ELIXIR, USP, 0.5 mg/5 mL, 8 fl.oz., Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL,	Drug	Class III	1
22 Dec 2016	TEMAZEPAM CAPSULES USP, 7.5 mg, 100 count bottles, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL	Drug	Class III	1
21 Oct 2015	RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 mL (16 fl oz), Rx only. Manufactured for: QU	Drug	Class III	1
7 Oct 2015	HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 3000 count bottles, Rx only, Manufactured for: Qualitest Pharmaceuticals, In	Drug	Class II	1
13 Aug 2015	AMPICILLIN CAPSULES, USP, 250 mg, 500 count bottles, Rx only, Manufactured for: DAVA Pharmaceuticals, Inc., Fort Lee, NJ	Drug	Class III	1
29 Jul 2015	Lisinopril Tablets, USP, 40 mg, a) 45-count bottle (NDC 0603-4214-60), b) 500-count bottle (NDC 0603-4214-28), Rx Only,	Drug	Class II	1
11 Oct 2012	Perphenazine Tablets, USP, 8 mg, 100-count tablets per bottle, Manufactured for: Qualitest Pharmaceuticals, Huntsville,	Drug	Class II	1
10 Sep 2012	HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg. for: QUALITEST PHAR	Drug	Class I	1
6 Jul 2012	HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP, 10 mg/5 mL, 1 PINT (473 mL) bottle, Rx only, Mfg. for: QUALITEST PHARMACEU	Drug	Class III	1

All 12 events for Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets."

What does Class I mean?

FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide and Puerto Rico"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 20 Jul 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.