Te­va is­sues re­call of fen­tanyl buc­cal tablets over la­bel­ing is­sue

Te­va is­sued a re­call over sev­er­al lots of its fen­tanyl buc­cal tablets used to treat can­cer pa­tients due to a la­bel­ing er­ror.

The FDA an­nounced April 28 that Te­va is­sued a na­tion­wide vol­un­tary re­call for 13 lots of the tablets, which were man­u­fac­tured by Te­va and la­beled for Mayne Phar­ma.

Ac­cord­ing to the FDA, safe­ty up­dates were omit­ted in the med­ica­tion guide pro­vid­ed with the re­called prod­ucts. A to­tal of 13 lots, or 364 tablets, with vary­ing strengths are be­ing tak­en off shelves, with ex­pi­ra­tion dates rang­ing from this year to 2024. The lots were shipped to Mayne be­tween Au­gust 2020 and Jan­u­ary 2022.

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