Drug product
Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. Ltd., Ahmedabad, India UPC 8 904218 700313
D-0332-2026
Product summary
- Event
- Event 98165
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 4 bottles /30 capsules each
- Official record key
drug-enforcement:D-0332-2026
Official wording
Reason: CGMP Deviations: product found to contain lead.
Code information: Lot: CAM040, Exp. 06/30/2029 Lot: CAL079-N, Exp. 09/30/2028
Distribution pattern: Product was distributed to one customer in NY.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations