Drug recall: Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehringer Ingelheim…

Class II FDA enforcement event 63630. Recall start date: 5 Nov 2012. Status in the FDA record: Terminated. Termination date: 18 Sep 2013.

Reason for recall, in the words of FDA

Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Boehringer Ingelheim Roxane Inc started this drug recall on 5 Nov 2012. The firm address in the FDA record is in Columbus, OH. FDA put the recall in Class II. FDA event 63630 has 1 product record. The first FDA enforcement report date is 5 Dec 2012. The record gives the status Terminated, with the termination date 18 Sep 2013.

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.

Nationwide

Recalling firm

Boehringer Ingelheim Roxane Inc, Columbus, OH.

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 63630: product records
Recall number	Product	Quantity	Class	Status	Report date
D-067-2013	Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT --- NDC 0597-0149-54	8,381 bottles	Class II	Terminated	5 Dec 2012

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 II: The middle of the three FDA recall classes.

The event in context

Drug events that started in 2012: 209
Share of these events in Class II: 56%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 13

Other events of the firm

Other FDA enforcement events of 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
28 Jul 2014	OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx only. Boehringer Ingelheim, Roxane Laboratorie	Drug	Class III	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

Boehringer Ingelheim Roxane Inc: all 13 events

Official channels

FDA enforcement report D-067-2013The 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 63630. https://recallregister.com/fda/ii/63630/. 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: Nationwide
What quantity of product is in FDA event 63630?: The FDA record gives this quantity: 8,381 bottles
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2012 have the same class?: 56% of the 209 drug events that started in 2012 are in Class II.