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Drug recall: Aspirin DR Enteric Coated Tablets, USP 325 mg, UD 750 tablets (25x30), Dist. By: McKesson Packaging Services a business

FDA enforcement event 68652 · Class III · initiated 19 Jun 2014 · status Terminated · terminated 27 Apr 2017

DrugVoluntary: Firm initiated1 product recordConcord, NC

Mckesson Packaging Services (Concord, NC) initiated this drug recall on 19 Jun 2014; FDA lists 1 product record under event 68652, classified Class III.

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 27 Apr 2017. Initiation: voluntary: firm initiated. Mckesson Packaging Services has 14 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

Mckesson Packaging Services, Concord, NC.

Reason for recall

"Failed Dissolution Specification; at the 12 month time interval."

Distribution

"Nationwide"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-1483-2014	Aspirin DR Enteric Coated Tablets, USP 325 mg, UD 750 tablets (25x30), Dist. By: McKesson Packaging Services a business unit of McKesson Corporation, concord, NC	1,511,250 tablets	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

14events on this register for the firm

Other enforcement events for Mckesson Packaging Services

Initiated	Product (first record)	Type	Class	Records
23 Apr 2018	Diltiazem HCl Extended-Release Capsules, USP 120 mg, 100-count bottles, Rx only, Mfg. By: Par Pharmaceutical One Ram Rid	Drug	Class III	3
26 Feb 2018	RANITIDINE Tablets, USP 150 mg UD 100 tablets (10x10), RX Only, Manufactured by: Amneal Pharmaceuticals, Hauppauge, NY 1	Drug	Class II	1
29 Jan 2018	Megestrol Acetate Oral Suspension, USP 400 mg/ 10mL (10 mL UD cups in boxes of 20 cups), Rx Only, Dist. By McKesson Pack	Drug	Class III	1
28 Aug 2017	Propafenone Hydrochloride tablets, 150 mg, packaged in 10 x 10 unit dose cards (100-count box), Rx only, Manufactured By	Drug	Class III	1
30 May 2017	BuPROPion HCL Tablets, USP, 75 mg, packaged as UD 100 tablets (10x10), Rx Only, Mfg by: Sandoz Inc., 508 Carnegie Center	Drug	Class III	1
23 Feb 2017	Aspirin Chewable Tablets, 81 mg, (NSAID*), packaged in UD 750 Tablets (25 x 30) tablets in blisters per carton, Dist. By	Drug	Class II	1
4 Jan 2017	Donepezil HCl tablets, 10mg, packaged in 10x10 blister packs per carton (100 Unit Dose) container, Rx only, Manufactured	Drug	Class III	1
15 Sep 2016	Xanax (Alprazolam) USP, CIV, 0.5 mg tablets , 10 x 10 blister cards per carton, Rx Only, Manufactured by Sandoz Inc., Pr	Drug	Class III	1
8 Sep 2016	Lansoprazole Delayed-Release Capsules, USP, 30 mg, packaged in 100-count cartons of 10 x 10 unit dose blister cards, Rx	Drug	Class III	1
12 Apr 2016	SKY Aspirin Chewable Tablets, 81 mg, Unit Dose 750 tablets (25 x 30) box, OTC, Distributed by: McKesson Packaging Servic	Drug	Class III	1

All 14 events for Mckesson Packaging Services

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Failed Dissolution Specification; at the 12 month time interval."

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: "Nationwide"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 27 Apr 2017. "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.