Recalls / Class II
Class IID-1316-2014
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*
- Affected lot / code info
- Lot #: F040, Exp 08/16
Why it was recalled
Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote.
Recalling firm
- Firm
- Flawless Beauty LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 1215 Main St, Asbury Park, New Jersey 07712-5940
Distribution
- Quantity
- unknown
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-04-29
- FDA classified
- 2014-05-13
- Posted by FDA
- 2014-05-21
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-1316-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.