Recalls / Active ingredient / Atropine Sulfate
Atropine Sulfate
6 FDA drug recalls involving the active ingredient “Atropine Sulfate” — 2 Class I.
| Date | Class | Product | Firm |
|---|---|---|---|
| 2024-12-16 | Class III | Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, | SOMERSET THERAPEUTICS LLC |
| 2023-12-21 | Class I | Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Onl | Pfizer Inc. |
| 2023-07-03 | Class II | Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials, Rx only, Manufactu | Accord Healthcare, Inc. |
| 2022-04-13 | Class II | Isopto Atropine (atropine sulfate ophthalmic solution) 1%, 5mL bottle, MFG: Alcon Surgical, NDC 0065-0303-55 | Mckesson Medical-Surgical Inc. Corporate Office |
| 2017-10-20 | Class I | diphenoxylate hydrochloride and atropine sulfate tablets, USP, 2.5 mg/0.025 mg, a) 100-count bottle (NDC 5976 | Pfizer Inc. |
| 2015-10-13 | Class III | Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) tablets, 100-count b | Rx PAK |