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 Lab

FDA recall notice · announced July 13, 2016 · Lyne Laboratories

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

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

Reason for recall

Subpotency: product assayed and found OOS for cyproheptadine

Notes

Distribution: NJ
Lot/code information: Lot #: CR1603, Exp 12/17
Quantity: 12,215 Bottles shipped to Rising Pharmaceuticals
Status: Terminated
Products in this recall event:
- 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 Pharmaceutical (D-1062-2016)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.