Class II · Moderate risk Ongoing
Oxycodone and Acetaminophen CII Tablets USP
Reason Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Hydrocodone Bitartrate and Acetaminophen Oral Solution
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotent (Multiple Ingredient) Drug: Low out of specification assay results for the hydrocodone bitartrate ingredient was found.
What was recalled
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.
- Recalling firm
- Mallinckrodt Inc.
- NDC code
- 0406-0375-16
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1430-2012
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Acetaminophen recalls
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Class II · Moderate risk Ongoing
Oxycodone and Acetaminophen CII Tablets USP
Reason Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Class II · Moderate risk Ongoing
Tylenol
Reason Defective Container
Class II · Moderate risk Ongoing
Acetaminophen 500mg Caffeine 65mg caplets
Reason Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg.
Class II · Moderate risk Ongoing
Acetaminophen Injection 1000 mg/100 mL
Reason Discoloration
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