D-1379-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 19, 2019
- Initiation Date
- May 21, 2019
- Termination Date
- October 6, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 177,408 bottles
Product Description
Anu-Med brand of Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12 suppositories per carton, NDC: 0904-7688-22, Distributed by Major Pharmaceuticals, Livonia MI 48152.
Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Distribution Pattern
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Code Information
Lot #s: 17L008, Exp. 05/2019; 17M011; 17M037, Exp. 06/2019; 18A015, Exp. 07/2019; 18B012; 18B023, Exp. 08/2019; 18K023; 18K029, Exp. 04/2020; 18L014, Exp. 05/2020; 19A001, Exp. 06/2020.