CLASS II Drug recall · Reported 19 Jul 2023 · FDA Enforcement Report
Atropine Sulfate Injection, USP 8 mg recalled by Accord Healthcare
Accord Healthcare is recalling Atropine Sulfate Injection, USP 8 mg per (0.4 mg per mL) Multiple Dose Vials, distributed nationwide in the US. The recall was initiated on 3 Jul 2023 and the FDA has classified it as Class II.
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-0917-2023
- FDA event ID
- 92639
- Recalling firm
- Accord Healthcare, Durham, NC
- Brand
- Atropine Sulfate
- Manufacturer
- Accord Healthcare Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Jul 2023
- FDA classified
- 13 Jul 2023
- Reported
- 19 Jul 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 3 Jul 2023 | Recall initiated by company | |
| 13 Jul 2023 | Classified by FDA | +10 days |
| 19 Jul 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: Particulate matter identified as fiber.
Product as listed by the FDA
Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials, Rx only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited Ahmedabad-382 210, India, NDC 16729-512-43.
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: Particulate matter identified as fiber.
Which lots are affected?
Lot #: M2210154 Exp. date 06/2025; M2212575 Exp. date 08/2025
Where was it sold?
Nationwide within the United States
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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
1 other product · FDA event 92639This product is part of a recall event; the main page for the event is Bivalirudin for Injection 250 mg-Dose Vials recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Bivalirudin for Injection 250 mg-Dose Vials recalledBivalirudin | Accord Healthcare | Particulate Matter | Nationwide |
More recalls from Accord Healthcare
All 106| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
Other Atropine recalls
All 25| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Atropine Sulfate injection, USP, 1 mg/mL recalled by American RegentAtropine Sulfate | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS III | Atropine Sulfate Ophthalmic Solution recalled by Somerset TherapeuticsAtropine Sulfate | Somerset Therapeutics | Potency & Assay | Nationwide |
| Drug | CLASS I | Atropine Sulfate Injection, USP 1 mg/ (0.1 mg/mL) recalled by PfizerAtropine Sulfate | Pfizer | Particulate Matter | Nationwide |
| Drug | CLASS II | Atropine Sulfate Ophthalmic Solution recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS III | Atropine Sulfate Ophthalmic Solution recalled by Akorn | Akorn | Potency & Assay | Nationwide |