Denison Pharmaceuticals, LLC
FDA issued a warning letter to Denison Pharmaceuticals, LLC (Lincoln, RI) following a January–February 2023 inspection that found significant CGMP violations including inadequate contamination investigations, failure to test for DEG/EG in high-risk components, and use of unvalidated microbiological test methods. Additionally, FDA determined that three homeopathic products — 'Colic Calm,' 'Colic Calm +,' and 'Nauzene Kids' — are unapproved new drugs based on disease-treatment claims on their labels and associated websites. The company issued a voluntary nationwide recall of four products in May 2023, and FDA warned that failure to correct violations could result in seizure, injunction, and withholding of approvals.
Flagged claims (9)
For Nausea & Upset Tummies
Promptly relieves nausea and upset tummies – even from the 'stomach flu' and 'car sickness'
The Easy Fix for Upset Stomachs & Nausea
Colic Calm® Plus is a professional strength formulation developed for babies that need extra help. Our Plus formula is enhanced with additional gas absorption properties . . . four more homeopathic remedies for added digestive support . . . amazing healing properties to quickly and safely eliminate the symptoms of infant gas, colic and upset stomach.
Trusted Relief for Upset Stomachs Caused by . . . Diet . . . Stomach Bug . . . Motion Sickness . . . Nervous Stomach
Colic Calm eases baby's discomfort often associated with gas, colic, hiccups and teething. Our gentle liquid formula is the #1 selling gripe water for infant gas & colic relief.
For Symptomatic relief of infant Colic, Gas & Reflux
Temporarily relieves the symptoms of infant: colic · gas · reflux · upset stomach · bloating · hiccups
For the relief of upset stomach and nausea, including that due to 'stomach flu,' 'car sickness' or overindulgences in food or drink.
Required actions (5)
your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).
On May 3, 2023, you issued a voluntary nationwide recall of the following four products: Safe tussin DM, DAY TIME Cough Relief; Safe tussin PM, NIGHT TIME Cough Relief; Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine; and Pin-Away PYRENTAL PAMOATE (Pyrantel base 50 mg / mL) Pinworm Treatment.
After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence.
Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.
you should engage a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm's compliance status with FDA.
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