Class II · Moderate risk
Acetaminophen and Codeine Phosphate Tablets
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
National Drug Code
Is NDC 13107-0059-99 recalled?
Acetaminophen and Codeine Phosphate · 1000 TABLET in 1 BOTTLE (13107-059-99)
Yes — this exact package was recalled
2 FDA recalls name the code 13107-0059-99 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.
- Active ingredient
- Acetaminophen and Codeine Phosphate
- Strength
- ACETAMINOPHEN 300 mg/1; CODEINE PHOSPHATE 30 mg/1
- Form
- Tablet · Oral
- Labeler
- Aurolife Pharma, LLC
- Type
- Human Prescription Drug · DEA CIII
- Product code
- 13107-0059
Recalls naming this package
Class II · Moderate risk
Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
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
- 13107-0014 Glycopyrrolate 3
- 13107-0031 Mirtazapine 2
- 13107-0001 Mirtazapine 1
- 13107-0046 Oxycodone and Acetaminophen 1
- 13107-0058 Acetaminophen and Codeine Phosphate 1
- 13107-0060 Acetaminophen and Codeine Phosphate 1
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