AUDIENCE: Health Professionals
ISSUE: FDA alerted health care professionals not to use injectable vitamin drug products distributed by Medical Supply Liquidators LLC in Clive, Iowa, with “Sunshine Labs” on the label. These products are manufactured by Compound Brothers Dominicana (also known as CB Inc.) in the Dominican Republic and sold as prescription injectable nutritional supplements. FDA has not approved these products and cannot be assured of their safety, effectiveness, or quality.
All lots of non-expired products from Compound Brothers Inc. and labeled as Sunshine Labs are being recalled by Medical Supply Liquidators. See the FDA Statement for a listing of all affected products.
RECOMMENDATION: Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[06/30/2014 - Statement - FDA]