Can we bypass confirmatory testing of DP based on Theoretical Calc. of NDSRI's

[Naiffer_Host]

Not NDMA, but we got yesterday reports of presence of NDSRI.

OTC Market Withdrawal of Diphenhydramine

Class II Recall Issued for Unisom Sleep Aid Due to Nitrosamine Impurities. Source: https://www.hmpgloballearningnetwork.com/site/pln/news/class-ii-recall-issued-unisom-sleep-aid-due-nitrosamine-impurities#:~:text=The%20recall%2C%20listed%20under%20US,to%20removal%20from%20the%20market. Chattem Inc. has voluntarily initiated a Class II recall of its Unisom SleepMinis (diphenhydramine HCl) 25 mg mini-capsules, distributed in 60-count bottles nationwide. The recall, listed under US Food and Drug …