D-1505-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 31, 2019
- Initiation Date
- June 21, 2019
- Termination Date
- October 27, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7392 bottles
Product Description
SORBUGEN NR (Dextromethorphan HBr, 15 mg; Glyceryl Guaiacolate (Guaifenesin), 150 mg) in each 7.5 mL 1 1/2 tsp), GRAPE FLAVOR, 16 Fl.oz. (473 mL) bottle, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-660-16.
Reason for Recall
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Distribution Pattern
Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
Code Information
All lots remaining within expiry.