Serious riskFDA DrugClass I

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

  1. 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).
  2. Do not use vials from the affected lots.
  3. 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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