FDA-Drug2012-08-08Class III
Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz (473 mL) bottle, Rx only, Mallinckrodt Inc., Hazelwood, MO 63042 USA, NDC 0406-0375-16, UPC 3 0406-0375-16 1.
Mallinckrodt Inc.
Hazard
Subpotent (Multiple Ingredient) Drug: Low out of specification assay results for the hydrocodone bitartrate ingredient was found.
Sold states
Nationwide
Affected count
41,100 bottles
Manufactured in
172 Railroad Avenue, N/A, Hobart, NY, United States
Products
Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz (473 mL) bottle, Rx only, Mallinckrodt Inc., Hazelwood, MO 63042 USA, NDC 0406-0375-16, UPC 3 0406-0375-16 1.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1430-2012Don't want to check this manually?
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