Mallinckrodt Recalls Hydrocodone and Acetaminophen Oral Solution for Low Potency
Mallinckrodt Inc. is recalling specific lots of Hydrocodone Bitartrate and Acetaminophen Oral Solution because the hydrocodone ingredient was found to be subpotent.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which is defined as unlikely to cause adverse health consequences. The hazard is a subpotent ingredient, which is a quality issue rather than a direct safety threat like contamination or mislabeling of a dangerous substance.
Plain-English summary
Mallinckrodt Inc. is recalling 41,100 bottles of Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz (473 mL) bottles. The affected product is prescription-only and was distributed nationwide. The recall involves specific lots with expiration dates of 05/13, 09/13, and 01/14.
The recall was initiated because low out-of-specification assay results were found for the hydrocodone bitartrate ingredient, indicating the product is subpotent. This means the medication may not contain the full amount of the active ingredient required to provide the intended therapeutic effect.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product matches the recalled lots, it should be returned to the pharmacy or supplier for replacement or refund. Patients should consult their healthcare provider regarding alternative treatment options if they have been using the affected medication.
The recalled product
- Product
- 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.
- Manufacturer
- Mallinckrodt Inc.
- Category
- Drug — Oral Solution
- Hazard
- Affected units
- 41,100
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 (6)
- Lot #: 0375T79384
- Exp 05/13
- 0375T81348
- Exp 09/13
- 0375U82277
- Exp 01/14
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Mallinckrodt Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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