Food, drugs, devices › Boehringer Ingelheim Roxane Inc

Drug recall: OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx only. Boehringer Ingelheim, Roxane Laboratorie

FDA enforcement event 68879 · Class III · initiated 28 Jul 2014 · status Terminated · terminated 29 May 2015

DrugVoluntary: Firm initiated1 product recordColumbus, OH

FDA enforcement event 68879 is a drug recall by Boehringer Ingelheim Roxane Inc of Columbus, OH, initiated 28 Jul 2014 and classified Class III, with 1 product record.

FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 27% of the 313 drug enforcement events initiated in 2014 carry the same class.

Status: Terminated, terminated 29 May 2015. Initiation: voluntary: firm initiated. Boehringer Ingelheim Roxane Inc has 13 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

Boehringer Ingelheim Roxane Inc, Columbus, OH.

Reason for recall

"Failed Stability Specifications: Out of specification result for preservative sodium benzoate."

Distribution

"U.S. Nationwide"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-1486-2014	OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx only. Boehringer Ingelheim, Roxane Laboratories. Roxane Laboratories, Inc. Columbus, Ohio 43216. NDC: 0054-0523-41.	2,149 Bottles	Class III	Terminated	6 Aug 2014

Context

27%of 2014 drug events are Class III313 events that year

1product record in this eventfirm median: 1

13events on this register for the firm

Other enforcement events for Boehringer Ingelheim Roxane Inc

Initiated	Product (first record)	Type	Class	Records
25 Sep 2015	FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories	Drug	Class III	2
24 Jul 2015	COMBIVENT RESPIMAT (ipratropium bromide and albuterol) Inhalation Spray, 20 mcg/100 mcg per actuation*, 4 Grams, 120 Met	Drug	Class II	1
2 Apr 2015	Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 count Bottles, Rx only, Roxane Laboratories,	Drug	Class II	1
1 May 2014	Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-	Drug	Class II	1
4 Apr 2014	Azathioprine Tablets USP, 50 mg, 100 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-	Drug	Class III	2
27 Mar 2014	Spiriva HandiHaler (tiotropium bromide inhalation powder), Do Not Swallow Spiriva Capsules, For Use With HandiHaler Only	Drug	Class III	1
30 Aug 2013	SPIRIVA HandiHaler (Tiotropium Bromide Inhalation Powder) Capsules 18 mcg per dose, Rx only, a) 10 count blister (NDC 05	Drug	Class III	1
14 Jun 2013	Prednisone Tablet USP, 20 mg tablets, packaged in blisters of ten (10) tablets per blister card, ten blister cards per c	Drug	Class III	1
3 Apr 2013	Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, Rx only, Boehringer Ingelheim, Roxane Laboratories, Inc. Colu	Drug	Class II	1
18 Mar 2013	Oxcarbazepine Tablets, 150 mg, packaged in a) 10 x 10 count Unit-Dose Tablets in blisters packaged in a carton (NDC 0054	Drug	Class III	1

All 13 events for Boehringer Ingelheim Roxane Inc

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Failed Stability Specifications: Out of specification result for preservative sodium benzoate."

What does Class III mean?

FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Where was the product distributed?

FDA's distribution pattern field reads: "U.S. Nationwide"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 29 May 2015. "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.