Drug product
Laroscorbine Platinium (vitamin C/collagen) injectable I.V. solution, 1 gm/0.35 gm, 5 mL ampoules, packaged in 10-count ampoules per box, Laboratories Roche Nicholas S.A., F-74240 Gaillard, - Tel.: 04 50 87 70 70, Fabricant : Produits Roche, 52, Bld du Parc, 92521 Neulilly -sur-Seine Cedex, barcode *3421357*
D-1316-2014
Product summary
- Event
- Event 68158
- Status
- Completed
- Classification
- Class II
- Quantity
- unknown
- Official record key
drug-enforcement:D-1316-2014
Official wording
Reason: Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote.
Code information: Lot #: F040, Exp 08/16
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote.