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.
Reported: July 19, 2023 Initiated: July 3, 2023 #D-0917-2023
Product Description
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.
Reason for Recall
Presence of Particulate Matter: Particulate matter identified as fiber.
Details
- Recalling Firm
- Accord Healthcare, Inc.
- Units Affected
- 2348 vials
- Distribution
- Nationwide within the United States
- Location
- Durham, NC
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Accord Healthcare, Inc.. Units affected: 2348 vials.
Why was this product recalled? ▼
Presence of Particulate Matter: Particulate matter identified as fiber.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 19, 2023. Severity: Moderate. Recall number: D-0917-2023.
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