CLASS III Drug recall · Reported 13 Sep 2017 · FDA Enforcement Report
Propafenone Hydrochloride tablets, 150 mg recalled
Mckesson Packaging Services is recalling Propafenone Hydrochloride tablets, 150 mg, distributed in Colorado, Illinois, Louisiana, Ohio, Pennsylvania. The recall was initiated on 28 Aug 2017 and the FDA has classified it as Class III.
Check your package
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-1128-2017
- FDA event ID
- 78020
- Recalling firm
- Mckesson Packaging Services, Concord, NC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 28 Aug 2017
- FDA classified
- 6 Sep 2017
- Reported
- 13 Sep 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 28 Aug 2017 | Recall initiated by company | |
| 6 Sep 2017 | Classified by FDA | +9 days |
| 13 Sep 2017 | 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
Failed moisture limits: Out of specification for moisture content.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Propafenone Hydrochloride tablets, 150 mg, packaged in 10 x 10 unit dose cards (100-count box), Rx only, Manufactured By: Watson Pharmaceuticals 311 Bonnie Circle Corona, CA 92880, NDC 63739-509-10
Where it was distributed
PA, OH, IL, CO, LA
Questions about this recall
Is Propafenone Hydrochloride tablets, 150 mg recalled?
Yes. Mckesson Packaging Services recalled Propafenone Hydrochloride tablets, 150 mg on 28 Aug 2017. The recall is Class III and its status is Terminated. Recall number D-1128-2017.
Why was it recalled?
Failed moisture limits: Out of specification for moisture content.
Which lots are affected?
Lot#: 0112313 Exp. 12/2017; 0113376 Exp. 06/2018; 0113645 Exp. 02/2019.
Where was it sold?
PA, OH, IL, CO, LA
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Mckesson Packaging Services
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Diltiazem HCl Extended-Release Capsules, USP 120 mg recalled | Mckesson Packaging Services | Potency & Assay | Nationwide |
| Drug | CLASS III | Diltiazem HCl Extended-Release Capsules, USP 240 mg recalled | Mckesson Packaging Services | Potency & Assay | Nationwide |
| Drug | CLASS III | Diltiazem CD (Diltiazem Hydrochloride Extended-Release recalled | Mckesson Packaging Services | Potency & Assay | Nationwide |
| Drug | CLASS II | Ranitidine Tablets, USP 150 mg UD recalled | Mckesson Packaging Services | Potency & Assay | Nationwide |
| Drug | CLASS III | Megestrol Acetate Oral Suspension, USP 400 mg/ UD cups in boxes recalled | Mckesson Packaging Services | Potency & Assay | Nationwide |
Other Propafenone recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Propafenone Hydrochloride Extended-Release Capsules 225mg recalledPropafenone Hydrochloride | Glenmark Pharmaceuticals Inc., U | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Propafenone Hydrochloride Extended-Release Capsules, USP 325mg recalledPropafenone Hydrochloride | Glenmark Pharmaceuticals Inc., U | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Propafenone Hydrochloride Extended-Release Capsules USP, 225mg recalledPropafenone Hydrochloride | Glenmark Pharmaceuticals Inc., U | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Propafenone Hydrochloride Extended-Release Capsules 325mg recalledPropafenone Hydrochloride | Glenmark Pharmaceuticals Inc., U | Manufacturing (CGMP) Deviations | Nationwide |