CLASS III Drug recall · Reported 21 Nov 2018 · FDA Enforcement Report
Metoprolol Tartrate Injection, USP 5mg/, vials recalled by RemedyRepack
RemedyRepack is recalling Metoprolol Tartrate Injection, USP 5mg/, vials, distributed in New York. The recall was initiated on 26 Oct 2018 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-0245-2019
- FDA event ID
- 81554
- Recalling firm
- RemedyRepack, Indiana, PA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 26 Oct 2018
- FDA classified
- 14 Nov 2018
- Reported
- 21 Nov 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 26 Oct 2018 | Recall initiated by company | |
| 14 Nov 2018 | Classified by FDA | +19 days |
| 21 Nov 2018 | 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 pH Specifications: High Out-of-Specification results for pH were obtained during stability testing.
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
Metoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifesciences Inc., North Brunswick, NJ 08902, NDC# 70518-0868-00
Where it was distributed
1 vial was distributed to a medical facility in Mayville, NY.
Questions about this recall
Why was it recalled?
Failed pH Specifications: High Out-of-Specification results for pH were obtained during stability testing.
Which lots are affected?
Lot #: A0A0253, Exp. 02/2019; Lot #: B0369427-112717, Exp. 08/2019
Where was it sold?
1 vial was distributed to a medical facility in Mayville, NY.
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 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.
More recalls from RemedyRepack
All 61| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clindamycin HCl Capsule, 300 mg, QTY recalled by RemedyRePack | RemedyRePack | Manufacturing (CGMP) Deviations | FL, PA, VA |
| Drug | CLASS II | Clindamycin HCl, QTY recalled by RemedyRepack | RemedyRepack | Manufacturing (CGMP) Deviations | PA |
| Drug | CLASS II | Carvedilol, QTY: per Blister Pack ( blister cards) recalled | RemedyRepack | Nitrosamine Impurity | FL |
| Drug | CLASS II | Duloxetine Delayed-Release Capsules, 60 mg, a) blister cards recalled | RemedyRepack | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Potassium Chloride Micro 10mEq recalled by RemedyRepack | RemedyRepack | Potency & Assay | Nationwide |
Other Metoprolol recalls
All 40| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* recalledMetoprolol Succinate | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Metoprolol Succinate Extended-Release Tablets recalledMetoprolol Succinate | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Metoprolol Succinate Extended-Release Tablets, 200 mg recalledMetoprolol Succinate | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Metoprolol Succinate Extended-Release Tablets, 25 mg bottles recalledMetoprolol Succinate | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Metoprolol Succinate Extended-Release Tablets, 50 mg bottles recalledMetoprolol Succinate | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |