The public is hereby warned by the Food and Drug Administration (FDA) to be vigilant about the drug products due for destruction last 28 August 2020 but were reported by Pascual Laboratories, Inc. as stolen from their waste treater, Cleanleaf International Corporation.
Below is the list of the drug products reported as part of theft:
PRODUCT NAME | PACKAGING | REG. NO. | BATCH/ LOT NO. | EXPIRY DATE |
Ascorbic Acid 500 mg Sugar-Coated Tablet (Poten-Cee) | Amber Blister pack x 10’s
(Box of 100’s) |
DR-9468 | 56SIE | 04/30/2022 or
30-APR-2022 |
Vitex Negundo L. (Lagundi Leaf) 600 mg/5 mL Syrup (Menthol) (Ascof Forte) |
120 mL Amber Bottle
(Box of 1’s) |
HMR-19 | 320SEE | 11/15/2022 or
15-NOV-2022 |
320SIF | 04/30/2022 or
30-APR-2022 |
|||
320SRE | 12/13/2022 or
13-DEC-2022 |
The batch/lot numbers mentioned above are not guaranteed by the FDA to be stored according to Good Storage Practice (GSP). Thus, the safety, efficacy and quality of these batches/lots are also not assured. These present safety risk and potential adverse health consequences. Therefore, consumers are instructed not to purchase or use the drug products with the stated batch/lot numbers.
All Local Government Units (LGU) and Law Enforcement Agencies (LEAs) are requested to ensure that the affected product batches/lots are not sold or made available in their localities or areas of jurisdiction.
For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of the abovementioned, kindly e-mail us via [email protected]. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. Any suspected adverse reaction experienced from the use of the product should be reported immediately to the FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill-out all of the required fields.
Dissemination of the information to all concerned is requested.
Attachment:-> FDA-Advisory-No.2020-1875