Reported Apr 17, 2024 · Ongoing
Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva…
Teva Pharmaceuticals USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teva Pharmaceuticals USA, Inc · 400 Interpace Pkwy Bldg A · Parsippany, NJ · 07054-1120
Is this the product you have?
- Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only
- Manufactured ForTeva Pharmaceuticals USA, Inc., Parsippany, NJ 07054. Blister Pack NDC 0591-2436-45, Carton NDC 0591-2436-15
- Lot codes and dates
Lot #: 100044259Exp 06/30/2025
- Amount recalled
- 5,304 3x10-cartons
Where it was sold
- Nationwide
Why it was recalled
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
This product could cause temporary or reversible health problems — stop using it.
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