b12 and l-carnitine shots 3000 Liquid Shots, Blue Razz, 16 fl oz (473 ml) it’s vegetarian NutraBio L-Carnitine 3000 - 16

35 (3): 40117, viii

Hair was observed: In stopper areas In proximity to the product In some cases, in direct contact with a sterile drug product Affected: Multiple drug products Multiple customers Both before and after Novo Nordisk acquisition Investigations: Were not initiated in a timely manner Lacked supporting data for assigned root causes Were not expanded to include potentially impacted batches or products Failed to assess CAPA effectiveness Trending: Ineffective due to restricted search terms and limited timeframes defined in procedures Batch disposition: Contaminated units were culled Remaining units were released Customers later reported the same contamination in the received product At least (b)(4) batches associated with mammalian hair were released post-acquisition Media Fill Failures More than five media fill batches have been terminated since November 2023

The safety evidence is assuring

Palamara et al., 1995, 1996