Mallinckrodt Recalls Hydrocodone and Acetaminophen Oral Solution Due to Expired Flavoring
Mallinckrodt Inc. is recalling specific lots of Hydrocodone Bitartrate and Acetaminophen Oral Solution because expired flavoring was used during manufacturing.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to CGMP deviations involving expired flavoring. As no specific illnesses or injuries are reported and the hazard is related to manufacturing compliance rather than a high-risk pathogen or structural defect, it falls under the Moderate category for minor labeling or low-risk contamination issues.
Plain-English summary
Mallinckrodt Inc. is recalling 44,330 bottles of Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz (473 mL) bottle. The affected product is prescription-only and was distributed nationwide. The recall involves specific lots with expiration dates ranging from July 2012 to September 2013.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, expired flavoring was used in the manufacturing of these lots. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
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 point of purchase for a refund or replacement. Patients should consult their healthcare provider regarding alternative pain management options if they have been prescribed this specific 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
- Affected units
- 44,330
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 #: 0375P76192
- Exp 07/12
- 0375T80512
- Exp 08/13
- 0375T81209
- Exp 09/13
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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