Class III · Low risk
Carton label: Testosterone Gel 1%
Defective Container - A defect in the side-seal which allows leakage of product.
National Drug Code
Is NDC 0591-3216-30 recalled?
Testosterone · 30 PACKET in 1 CARTON (0591-3216-30) / 2.5 g in 1 PACKET (0591-3216-17)
Yes — this exact package was recalled
3 FDA recalls name the code 0591-3216-30 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.
1 of these recalls is still ongoing.
- Active ingredient
- Testosterone
- Strength
- TESTOSTERONE 10 mg/g
- Form
- Gel · Topical
- Labeler
- Actavis Pharma, Inc.
- Type
- Human Prescription Drug · DEA CIII
- Product code
- 0591-3216
Recalls naming this package
Class II · Moderate risk
Testosterone Gel 1%
Superpotent Drug: Out of specification assay result was obtained during stability testing.
Class III · Low risk
Testosterone Gel 1%
Superpotent Drug: High out-of-specification assay results were obtained during 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
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