Recall Register

Food, drugs, devices › McKesson Packaging Services

Drug recall: Venlafaxine Hydrochloride, Extended Release Capsules, 150 mg, UD-100 Tablets per Box (10 x 10), Rx Only, Manufactured by

FDA enforcement event 67747 · Class III · initiated 3 Mar 2014 · status Terminated · terminated 14 Aug 2014

DrugVoluntary: Firm initiated1 product recordConcord, NC

McKesson Packaging Services (Concord, NC) initiated this drug recall on 3 Mar 2014; FDA lists 1 product record under event 67747, 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 14 Aug 2014. 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: Out of Specification dissolution results at 12 month interval."

Distribution

"Nationwide"

Product records

Recall numberProductQuantityClassStatusReport date
D-1167-2014Venlafaxine Hydrochloride, Extended Release Capsules, 150 mg, UD-100 Tablets per Box (10 x 10), Rx Only, Manufactured by: Teva Pharmaceuticals USA, 1090 Horsham Rd, North Wales, PA 19454, NDC 63739-0512-101,557 BoxesClass IIITerminated26 Mar 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

InitiatedProduct (first record)TypeClassRecords
23 Apr 2018Diltiazem HCl Extended-Release Capsules, USP 120 mg, 100-count bottles, Rx only, Mfg. By: Par Pharmaceutical One Ram RidDrugClass III3
26 Feb 2018RANITIDINE Tablets, USP 150 mg UD 100 tablets (10x10), RX Only, Manufactured by: Amneal Pharmaceuticals, Hauppauge, NY 1DrugClass II1
29 Jan 2018Megestrol Acetate Oral Suspension, USP 400 mg/ 10mL (10 mL UD cups in boxes of 20 cups), Rx Only, Dist. By McKesson PackDrugClass III1
28 Aug 2017Propafenone Hydrochloride tablets, 150 mg, packaged in 10 x 10 unit dose cards (100-count box), Rx only, Manufactured ByDrugClass III1
30 May 2017BuPROPion HCL Tablets, USP, 75 mg, packaged as UD 100 tablets (10x10), Rx Only, Mfg by: Sandoz Inc., 508 Carnegie CenterDrugClass III1
23 Feb 2017Aspirin Chewable Tablets, 81 mg, (NSAID*), packaged in UD 750 Tablets (25 x 30) tablets in blisters per carton, Dist. ByDrugClass II1
4 Jan 2017Donepezil HCl tablets, 10mg, packaged in 10x10 blister packs per carton (100 Unit Dose) container, Rx only, ManufacturedDrugClass III1
15 Sep 2016Xanax (Alprazolam) USP, CIV, 0.5 mg tablets , 10 x 10 blister cards per carton, Rx Only, Manufactured by Sandoz Inc., PrDrugClass III1
8 Sep 2016Lansoprazole Delayed-Release Capsules, USP, 30 mg, packaged in 100-count cartons of 10 x 10 unit dose blister cards, Rx DrugClass III1
12 Apr 2016SKY Aspirin Chewable Tablets, 81 mg, Unit Dose 750 tablets (25 x 30) box, OTC, Distributed by: McKesson Packaging ServicDrugClass III1

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: Out of Specification dissolution results at 12 month 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 14 Aug 2014. "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.