AuroMedics Recalls Acetaminophen Injection Due to Discoloration and pH Failures
AuroMedics Pharma LLC is recalling 3,094 cartons of Acetaminophen Injection 1,000 mg/100 mL nationwide due to discoloration and failed pH specifications.
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: The FDA classified this recall as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant quality failures like pH deviations in injectable drugs.
Plain-English summary
AuroMedics Pharma LLC is recalling 3,094 cartons of Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose Vial, For Intravenous Use Only. The product is distributed by AuroMedics Pharma LLC and manufactured in India. The recall covers specific lots with expiration dates in September and October 2022.
The recall was initiated because the product exhibited discoloration and failed pH specifications. The FDA has classified this recall as Class II, indicating a situation that might cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
The affected product was distributed nationwide. Healthcare providers and pharmacies should stop using the recalled product and contact AuroMedics Pharma LLC for further instructions. Consumers should not use the product and should contact their healthcare provider if they have questions.
The recalled product
- Product
- ACETAMINOPHEN (ACETAMINOPHEN)
- Brand
- ACETAMINOPHEN
- Manufacturer
- AuroMedics Pharma LLC
- Category
- Drug — Prescription Injectable
- Affected units
- 3,094
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 (11)
- CAT200002 exp 9/2022
- CAT200004 exp 9/2022
- CAT200005 exp 9/2022
- CAT200008 exp 9/2022
- CAT200009 exp 9/2022
- CAT200013 exp 10/2022
- CAT200014 exp 10/2022
- CAT200015 exp 10/2022
- CAT200016 exp 10/2022
- CAT200017 exp 10/2022
- CAT200018 exp 10/2022
UPCs (1)
- 0355150307012
Distribution
Distributed nationwide across the United States.
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