D-0104-2027 Class II Ongoing
FDA drug recall D-0104-2027 was initiated by Fei Fah Medical Manufacturing Pte. Ltd. on Oct 23, 2026 and is designated Class II. Reason for recall: CGMP Deviations The recall status is ongoing. Affected quantity: 171,120 units.
Recall details
- Product Type
- Drugs
- Report Date
- Nov 4, 2026
- Initiation Date
- Oct 23, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 171,120 units
Product description
ULTRA STRENTGH, ELECTRIC MIDICATED BALM (menthol 16% and methyl salicylate 32%) packaged in a) Net 2.45 oz (70g) (NDC 63299-001-01) and b) 10g (NDC 63299-001-02), Manufactured by Fei Fah Medical Mfg Pte Ltd, Singapore, U.S Distributor: SOLISTICE MEDICINE COMPANY, 215 West Ann Street, Los Angeles, CA 90012
Reason for recall
CGMP Deviations
Distribution pattern
Nationwide within the U.S
Code information
Lot: a)23FEBU7001-019, Exp. Date: October 2028; 24FEBU7001-020, Exp. Date: November 2029. b) 23FEBU1001-9, Exp. Date: October 2028; 24FEBU1001-004, Exp. Date: November 2029.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0104-2027
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026