Drug recall: RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 mL (16 fl oz), Rx only. Manufactured for…

Class III FDA enforcement event 72493. Recall start date: 21 Oct 2015. Status in the FDA record: Terminated. Termination date: 23 Oct 2016.

Reason for recall, in the words of FDA

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

Class III, in the words of FDA

a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences

Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals started this drug recall on 21 Oct 2015. The firm address in the FDA record is in Huntsville, AL. FDA put the recall in Class III. FDA event 72493 has 1 product record. The first FDA enforcement report date is 11 Nov 2015. The record gives the status Terminated, with the termination date 23 Oct 2016.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

U.S. Nationwide

Recalling firm

Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals, Huntsville, AL.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 72493: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0162-2016	RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 mL (16 fl oz), Rx only. Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC: 0603-9418-58.	61,146 Bottles	Class III	Terminated	11 Nov 2015

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class III: The lowest of the three FDA recall classes.

The event in context

Drug events that started in 2015: 292
Share of these events in Class III: 31%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 12

Other events of the firm

Other FDA enforcement events of 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
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
6 Dec 2012	Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg, packaged in a) 30-count bottles, NDC 0603-3888-16;	Drug	Class I	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

Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals: all 12 events

Official channels

FDA enforcement report D-0162-2016The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 72493. https://recallregister.com/fda/iii/72493/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: U.S. Nationwide
What quantity of product is in FDA event 72493?: The FDA record gives this quantity: 61,146 Bottles
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2015 have the same class?: 31% of the 292 drug events that started in 2015 are in Class III.