Brevital Sodium vials recalled for particulate matter contamination
Par Health USA is recalling certain lots of Brevital Sodium (methohexital sodium) for injection, a 500 mg multiple-dose vial sold in the US and Canada. The vials may contain particles identified as cellulose. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All Paragon 28 recalls
What to do
- Check the lot number and expiration date on the vial carton or label. The affected lots are 86930 (exp. 02/2028) and 88623 (exp. 04/2028).
- Do not use vials from the affected lots.
- Contact your pharmacy, hospital, or supplier about returning the product or getting a replacement.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Brevital Sodium (Methohexital Sodium), For Injection, USP, 500 mg/vial, 500 mg Multiple Dose Vial,, Rx only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC: 42023-105-01.
- Sold in
- Nationwide
- Made for
- Adults (under 0 months)
Details
- Units affected
- 20,567 vials
- Illnesses reported
- None reported
- Manufactured in
- 870 Parkdale Rd, Rochester, Michigan, United States
- Classification
- Class I
- Recall number
- D-0156-2027
In the FDA's words
- Description
- Brevital Sodium (Methohexital Sodium), For Injection, USP, 500 mg/vial, 500 mg Multiple Dose Vial,, Rx only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC: 42023-105-01. Presence of Particulate Matter; Particulates identified as cellulose Lot: 86930, Exp. 02/2028; 88623, Exp. 04/2028. Distribution: US Nationwide and Canada Affected quantity: 20,567 vials
- Hazard
- Presence of Particulate Matter; Particulates identified as cellulose
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