Class III · Low risk Terminated
Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ…
Reason Failed Impurities/Degradation Specifications
Atropine Sulfate Injection, USP 1.2 mg/3 mL (0.4 mg/mL) syringe, packaged in 5 x 3 mL…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
What was recalled
Atropine Sulfate Injection, USP 1.2 mg/3 mL (0.4 mg/mL) syringe, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility 4500 12th Street Extension, West Columbia, SC 29172, NDC: 69374-935-03
- Recalling firm
- Nephron Sterile Compounding Center LLC
- Origin
- SC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1246-2022
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Atropine recalls
See all
Class I · High risk Ongoing
Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only, 10 mL Syringe…
Reason Presence of Particulate Matter; identified as glass
Class II · Moderate risk Terminated
Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials, Rx only, Manufactured for: Accord…
Reason Presence of Particulate Matter: Particulate matter identified as fiber.
Class II · Moderate risk Ongoing
Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, packaged in a) 2 mL bottles b) 5 mL bottles…
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class III · Low risk Ongoing
Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Distributed by…
Reason Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
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