Class II · Moderate risk
Zenatane (isotretinoin)
Failed Dissolution Specifications: out of specification results observed for low dissolution.
National Drug Code
Is NDC 55111-0135-81 recalled?
Zenatane · 3 BLISTER PACK in 1 CARTON (55111-135-81) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (55111-135-79)
Yes — this exact package was recalled
2 FDA recalls name the code 55111-0135-81 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
- Isotretinoin
- Strength
- ISOTRETINOIN 10 mg/1
- Form
- Capsule, Gelatin Coated · Oral
- Labeler
- Dr. Reddy's Laboratories Limited
- Type
- Human Prescription Drug
- Product code
- 55111-0135
Recalls naming this package
Class III · Low risk
Zenatane (isotretinoin)
Failed dissolution specifications - low dissolution results at S3 stage.
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
- 55111-0121 Atorvastatin Calcium 4
- 55111-0123 Atorvastatin Calcium 4
- 55111-0180 Tizanidine 4
- 55111-0136 Zenatane 3
- 55111-0179 Tizanidine 3
- 55111-0320 Glimepiride 3
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