Zenatane (isotretinoin) Capsules, USP, 10 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-135-81
Reported: June 14, 2017 Initiated: May 22, 2017 #D-0883-2017
Product Description
Zenatane (isotretinoin) Capsules, USP, 10 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-135-81
Reason for Recall
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Details
- Recalling Firm
- Dr. Reddy's Laboratories, Inc.
- Units Affected
- 13,221 cartons
- Distribution
- Nationwide in the USA and Puerto Rico
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
Zenatane (isotretinoin) Capsules, USP, 10 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-135-81. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 13,221 cartons.
Why was this product recalled? ▼
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 14, 2017. Severity: Moderate. Recall number: D-0883-2017.
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