Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054. Blister Pack NDC 0591-2436-45, Carton NDC 0591-2436-15
Reported: April 17, 2024 Initiated: March 28, 2024 #D-0439-2024
Product Description
Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054. Blister Pack NDC 0591-2436-45, Carton NDC 0591-2436-15
Reason for Recall
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
Details
- Recalling Firm
- Teva Pharmaceuticals USA, Inc
- Units Affected
- 5,304 3x10-cartons
- Distribution
- Nationwide in the USA
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054. Blister Pack NDC 0591-2436-45, Carton NDC 0591-2436-15. Recalled by Teva Pharmaceuticals USA, Inc. Units affected: 5,304 3x10-cartons.
Why was this product recalled? ▼
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 17, 2024. Severity: Moderate. Recall number: D-0439-2024.
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