Class III · Low risk
Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL
Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance
National Drug Code
Is NDC 66689-0023-16 recalled?
Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL
Yes — this exact package was recalled
3 FDA recalls name the code 66689-0023-16 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
This code is not in the current FDA NDC directory — usual for a product that has since been discontinued or repackaged. The details below come from the recall notices themselves.
Recalls naming this package
Class II · Moderate risk
Hydrocodone Bitartrate and Acetaminophen Oral Solution
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk
Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL
Impurities/Degradation Products: exceeded specification at 3 month stability testing
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Other recalled products from this labeler
- 66689-0037 See recall 5
- 66689-0008 See recall 4
- 66689-0031 See recall 3
- 66689-0036 See recall 3
- 66689-0038 See recall 3
- 66689-0039 See recall 2
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