Retail Level Recall

06/18/2019 Dear Member, Torrent Pharma, Inc. initiated a voluntary recall on May 21, 2019, to the Retail Level for OTC products sold under the Major/ Rugby distributor labels. Torrent Pharma, Inc. is recalling all products, within expiry, manufactured at its Levittown, PA facility due to the potential product contamination with Burkholderia cepacia (B. cepacia) and Ralstonia pickettii (R. pickettii). Pharmaceuticals contaminated with these bacteria may pose a potential risk to immunocompromised patients. This includes patients with cystic fibrosis and persons with decreased immunity such as neonates, infants, and the elderly. Some infections could be serious and potentially life-threatening in at-risk patient populations. To date, Torrent Pharma, Inc. has not received any reports of adverse events related to this recall. This recall is being executed with the knowledge of the Food and Drug Administration. Mutual Drug item numbers and NDC’s are listed below.

Item # Description NDC

366-922 KID KARE LIQUID 4 OZ RUGBY 00536-2310-97 636-373 BISACODYL SUPPOSITORIES 10 MG 12 RUGBY 00536-1355-12 636-431 BISACODYL SUPPOSITORIES 10 MG 100 RUGBY 00536-1355-01 641-613 PSEUDOEPHEDRINE SYRUP 4 OZ RUGBY 00536-1850-97

807-453 PSEUDOEPHEDRINE HCL SYRUP 30MG/5ML 480ML RUGB 00536-1850-85 635-136 APAP ELIXIR CHERRY 16 OZ RUGBY 00536-0122-85

To view the entire recall notice and to see a complete list of all affected products and lots, please visit the recalls page on www.MDmembers.com.

With this recall, you are asked to:

• Check your product for the affected lots and stop dispensing and quarantine all impacted product. • Please return any recalled products to Mutual Drug Attn: Returns/Recalls no later than August 23, 2019

for credit. • Contact Nikki Basinger with Mutual Drug with any additional questions you may have (919) 598-4902.