December 2017 FDA Recall Simvastatin by Hetero Labs, Ltd. - Unit Iii
D-0223-2018 - Presence of foreign substance
This Class III drug recall was voluntarily initiated by Hetero Labs, Ltd. - Unit Iii on December 22, 2017 for the product Simvastatin. The FDA reported the reason for recall as presence of foreign substance. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0223-2018
Presence of foreign substance: metallic razor blade was found in one bottle.
12-22-2017
01-24-2018
N/A
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Hetero Labs, Ltd. - Unit III
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S.A. nationwide
03-23-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured by: Hetero (trademark), Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India, NDC 31722-513-10
Batch or Lot Expiration Information
Lot# : E171280, Exp 06/19
