Drug Enforcement D-0439-2024

Superpotent Drug: The 3-month stability result for assay was found to be above specification limit

Status

Ongoing

Classification

Class II

Report Date

April 17, 2024

Termination Date

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Product Information

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
Product quantity
5,304 3x10-cartons
Reason for recall
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Teva Pharmaceuticals USA, Inc
Address
400 Interpace Pkwy Bldg A, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0439-2024
Event ID
94294
Recall initiation date
March 28, 2024
Center classification date
April 8, 2024
Code info
Lot #: 100044259, Exp 06/30/2025.
More code info
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