CLASS I Drug recall · Reported 30 Jul 2014 · FDA Enforcement Report

Oxycodone HCl Oral Concentrate, 20 mg/mL, Rx recalled

Shamrock Medical Solutions Group is recalling Oxycodone HCl Oral Concentrate, 20 mg/mL, Rx (C-II) Packaged and labeled as Morphine, distributed in Colorado, Massachusetts, Ohio, Texas, Wyoming. The recall was initiated on 27 Sep 2011 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesLot #: 002HZI Use By: 7/20/2013 NDC: 00527-1426-36

Quantity recalled55/1 mL/20mg/mL syringe

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1447-2014
FDA event ID: 64611
Recalling firm: Shamrock Medical Solutions Group, Lewis Center, OH
Classification: Class I
Status: Terminated
Recall initiated: 27 Sep 2011
FDA classified: 23 Jul 2014
Reported: 30 Jul 2014
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Packaging Defects
Drug class: Pain Medication

Timeline

27 Sep 2011	Recall initiated by company
23 Jul 2014	Classified by FDA	+1030 days
30 Jul 2014	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Labeling: Label Mix up; product labeled as Morphine Sulfate 20 mg/mL actually contained OxyCODONE HCl 20 mg/mL

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Oxycodone HCl Oral Concentrate, 20 mg/mL, Rx (C-II) Packaged and labeled as Morphine Sulfate 20 mg/mL, Mfg: Lannett Co. Inc., Re-Packaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfr: Cody Laboratories Inc., Cody, WY NDC 00527-1426-36

Where it was distributed

Product was shipped to the following states: CO, MA, OH, TX & WY.

Colorado Massachusetts Ohio Texas Wyoming

Questions about this recall

Why was it recalled?

Labeling: Label Mix up; product labeled as Morphine Sulfate 20 mg/mL actually contained OxyCODONE HCl 20 mg/mL

Which lots are affected?

Lot #: 002HZI Use By: 7/20/2013 NDC: 00527-1426-36

Where was it sold?

Product was shipped to the following states: CO, MA, OH, TX & WY.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

5 other products · FDA event 64611

This product is part of a recall event; the main page for the event is metFORMIN ER Tablets, 500 mg, Rx, Packaged recalled.

Reported	Class	Recall	Company	Reason	Where
30 Jul 2014	CLASS I	metFORMIN ER Tablets, 500 mg, Rx, Packaged recalled	Shamrock Medical Solutions Group	Packaging Defects	5 states
30 Jul 2014	CLASS II	Docusate Calcium Softgel Capsules, 240 mg recalled	Shamrock Medical Solutions Group	Packaging Defects	5 states
30 Jul 2014	CLASS I	Taztia XT (Diltiazem HCl) Capsules, 120 mg, Rx, Packaged recalled	Shamrock Medical Solutions Group	Packaging Defects	5 states
30 Jul 2014	CLASS II	Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg recalledSulfamethoxazole And Trimethoprim	Shamrock Medical Solutions Group	Packaging Defects	5 states
30 Jul 2014	CLASS II	Pramipexole Dihydrochloride Tablets, 0.5 mg, Rx recalled	Shamrock Medical Solutions Group	Packaging Defects	5 states

Reported	Class	Recall	Company	Reason	Where
30 Jul 2014Drug	CLASS II	Pramipexole Dihydrochloride Tablets, 0.5 mg, Rx recalled	Shamrock Medical Solutions Group	Packaging Defects	5 states
30 Jul 2014Drug	CLASS II	Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg recalledSulfamethoxazole And Trimethoprim	Shamrock Medical Solutions Group	Packaging Defects	5 states
30 Jul 2014Drug	CLASS I	Taztia XT (Diltiazem HCl) Capsules, 120 mg, Rx, Packaged recalled	Shamrock Medical Solutions Group	Packaging Defects	5 states
30 Jul 2014Drug	CLASS II	Docusate Calcium Softgel Capsules, 240 mg recalled	Shamrock Medical Solutions Group	Packaging Defects	5 states
30 Jul 2014Drug	CLASS I	metFORMIN ER Tablets, 500 mg, Rx, Packaged recalled	Shamrock Medical Solutions Group	Packaging Defects	5 states