June 2016 FDA Recall Drug by Lyne Laboratories, Inc.
D-1062-2016 - Subpotency

This Class III drug recall was voluntarily initiated by Lyne Laboratories, Inc. on June 7, 2016 for the product Drug. The FDA reported the reason for recall as subpotency. The product was distributed in NJ and the recall is currently terminated.

Recall Number: D-1062-2016

Reason for Recall
Subpotency: product assayed and found OOS for cyproheptadine
Initiated
06-07-2016
Reported
07-13-2016
Quantity
12,215 Bottles shipped to Rising Pharmaceuticals

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74319
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Lyne Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NJ
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-03-2017
Product Description About Product Description
Full technical description of the product.
Cyproheptadine Hydrochloride Syrup, Oral Solution USP, 2 mg/5 mL, packaged in an amber glass 473 mL (one pint) bottle with child-resistant screw closure, Rx only, Distributed by: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Manufactured by: Lyne Laboratories, Inc., Brockton, MA 02301, NDC 64980-0504-48

Batch or Lot Expiration Information

Lot# : CR1603, Exp 12/17