Hyoscyamine Sulfate Elixir 0.125 mg per 5 mL, Rx Only, 473 mL (16 oz.) bottle, NDC:39328-048-16, Patrin Pharma, Skokie IL 60076.

Reason: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information: Lot #s: 17F021, Exp. 06/2019; 17G013, Exp. 07/2019; 17K010, Exp. 10/2019; 18E015, Exp. 05/2020; 18F029; 18F031; 18F042, Exp. 06/2020; 18G024, Exp. 07/2020.

Distribution pattern: Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.