Atropine Sulfate Injection Recalled for Glass Particulate Matter Contamination
Pfizer Inc. is recalling Atropine Sulfate Injection due to glass particulate matter contamination in lot GY2496. This FDA Class I recall affects 24,400 cartons distributed nationwide in the USA and Puerto Rico.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall is classified as FDA Class I, which per the severity rubric results in a minimum score of 4 (Severe). No deaths, hospitalizations, or injuries have been reported in the source text.
Plain-English summary
Pfizer Inc. is recalling Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL) in Lifeshield Glass ABBOJECT Unit of Use Syringes due to the presence of glass particulate matter. The affected product is lot GY2496 with an expiration date of February 1, 2025. This is an FDA Class I recall, the most serious category used by the FDA for drug recalls.
Approximately 24,400 cartons of the affected lot have been distributed nationwide in the United States and Puerto Rico. Healthcare facilities and patients who have received this product from the affected lot should cease use immediately.
Patients and healthcare providers who have questions about this recall or believe they may have this product should contact their healthcare provider or pharmacist. Pharmacies and healthcare facilities should review their inventory and contact Pfizer Inc. for return instructions and product replacement.
The recalled product
- Product
- ATROPINE SULFATE (ATROPINE SULFATE)
- Brand
- ATROPINE SULFATE
- Manufacturer
- Pfizer Inc.
- Hazard
- glass-contamination
- foreign-body
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot GY2496
- Exp 02/01/2025
Distribution
Distributed nationwide across the United States.
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