Claravis (isotretinoin capsules USP), 10mg, packaged in carton containing 3 Blister Packs of 10 Capsules Each (30 Capsules total); Rx only, TEVA PHARMACEUTICALS USA, Sellersville, PA 18960. NDC 00555-1054-86
Reported: October 12, 2016 Initiated: August 5, 2016 #D-0005-2017
Product Description
Claravis (isotretinoin capsules USP), 10mg, packaged in carton containing 3 Blister Packs of 10 Capsules Each (30 Capsules total); Rx only, TEVA PHARMACEUTICALS USA, Sellersville, PA 18960. NDC 00555-1054-86
Reason for Recall
Failed Impurities/Degradation Specifications.
Details
- Recalling Firm
- Teva North America
- Units Affected
- 3,569 capsules
- Distribution
- Nationwide
- Location
- Horsham, PA
Frequently Asked Questions
What product was recalled? ▼
Claravis (isotretinoin capsules USP), 10mg, packaged in carton containing 3 Blister Packs of 10 Capsules Each (30 Capsules total); Rx only, TEVA PHARMACEUTICALS USA, Sellersville, PA 18960. NDC 00555-1054-86. Recalled by Teva North America. Units affected: 3,569 capsules.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 12, 2016. Severity: Low. Recall number: D-0005-2017.
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