Drug 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
D-1062-2016
Product summary
- Event
- Event 74319
- Status
- Terminated
- Classification
- Class III
- Quantity
- 12,215 Bottles shipped to Rising Pharmaceuticals
- Official record key
drug-enforcement:D-1062-2016
Official wording
Reason: Subpotency: product assayed and found OOS for cyproheptadine
Code information: Lot #: CR1603, Exp 12/17
Distribution pattern: NJ
Derived failure modes
-
Potency or specification failure
Subpotency