FDA-Drug2022-02-09Class II

Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0808-02

Teva Pharmaceuticals USA
Hazard

Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution.

Sold states
nationwide in the USA
Affected count
1,175 Bottles
Manufactured in
400 Interpace Pkwy, N/A, Parsippany, NJ, United States
Products
Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0808-02

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0520-2022

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