Recalls / Class III
Class IIID-1062-2016
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
- Affected lot / code info
- Lot #: CR1603, Exp 12/17
Why it was recalled
Subpotency: product assayed and found OOS for cyproheptadine
Recalling firm
- Firm
- Lyne Laboratories, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 10 Burke Dr, N/A, Brockton, Massachusetts 02301-5505
Distribution
- Quantity
- 12,215 Bottles shipped to Rising Pharmaceuticals
- Distribution pattern
- NJ
Timeline
- Recall initiated
- 2016-06-07
- FDA classified
- 2016-07-05
- Posted by FDA
- 2016-07-13
- Terminated
- 2017-02-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1062-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.