Class III
Terminated
Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020 NDC 42794-016-10.
- Company
- Sigmapharm Laboratories Llc
- Recall Initiated
- April 19, 2021
- Posted
- May 26, 2021
- Recall Number
- D-0379-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 6266 bottles
- Firm Location
- Bensalem, PA, United States
Reason for Recall
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Distribution
Nationwide in the US
Lot / Code Info
Lots # 2012501, 2012601 , 2012701, & 2100701, Exp. AUG 2022
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