# Ipca Laboratories Limited · 66-41 · INDIA — FDA import alert red lists: firms subject to detention without physical examination

For Ipca Laboratories Limited · 66-41 · INDIA, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is INDIA; product code is 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 09/30/2009; address is P.O. Sejavta , Ratlam, Madhya Pradesh INDIA, verified against its source on 2026-09-16.

- **Firm:** Ipca Laboratories Limited _(verified: appears in the quote below)_
- **Import alert:** 66-41
- **Import alert name:** Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- **Country:** INDIA _(verified: appears in the quote below)_
- **Address:** P.O. Sejavta , Ratlam, Madhya Pradesh INDIA _(verified: appears in the quote below)_
- **Date published:** 09/30/2009 _(verified: appears in the quote below)_
- **Product code:** 66 V - - 99 Miscellaneous Patent Medicines, Etc. _(verified: appears in the quote below)_
- **FDA notes:** 8/22/2008. Piccan Teething Remedy. The combination of paracetamol (acetaminophen) and diphenhydramine has not been evaluated under the OTC Drug Review for use in relieving children's teething pain and associated troubles. The labeling contains structure/function claims; such as using the product to relieve childrens teething pains; making this product a drug under 201(g)(1) of the FFDCA. Further; we are not aware that this drug is generally accepted as safe and effective for its labeled uses. Consequently; this drug appears to be a new drug. _(verified: appears in the quote below)_

## What the source says

> Ipca Laboratories Limited Date Published : 09/30/2009 P.O. Sejavta , Ratlam, Madhya Pradesh INDIA 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 09/30/2009 Notes: 8/22/2008. Piccan Teething Remedy. The combination of paracetamol (acetaminophen) and diphenhydramine has not been evaluated under the OTC Drug Review for use in relieving children's teething pain and associated troubles. The labeling contains structure/function claims; such as using the product to relieve childrens teething pains; making this product a drug under 201(g)(1) of the FFDCA. Further; we are not aware that this drug is generally accepted as safe and effective for its labeled uses. Consequently; this drug appears to be a new drug.

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_190.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).