D-1062-2016 Class III Terminated
FDA drug recall D-1062-2016 was initiated by Lyne Laboratories, Inc. on June 7, 2016 and is designated Class III. Reason for recall: Subpotency: product assayed and found OOS for cyproheptadine The recall status is terminated (terminated February 3, 2017). Affected quantity: 12,215 Bottles shipped to Rising Pharmaceuticals.
Recall Details
- Product Type
- Drugs
- Report Date
- July 13, 2016
- Initiation Date
- June 7, 2016
- Termination Date
- February 3, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,215 Bottles shipped to Rising Pharmaceuticals
Product Description
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
Reason for Recall
Subpotency: product assayed and found OOS for cyproheptadine
Distribution Pattern
NJ
Code Information
Lot #: CR1603, Exp 12/17