Lidocaine Ointment USP, 5%, Speermint Flavor, 50 g Jar, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, L6T1C, Canada, Dist…
SUN PHARMA /TARO · Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).
- Status
- Ongoing
- City
- Hawthorne
- State
- NY
- Country
- United States
- Classification
- Class II
- Product type
- Drugs
- Event ID
- 99794
- Recalling firm
- SUN PHARMA /TARO
- Address 1
- 3 Skyline Dr
- Address 2
- N/A
- Postal code
- 10532-2174
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
- Recall number
- D-0848-2026
- Product quantity
- 65,328 50g jars
- Reason for recall
- Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).
- Recall initiation date
- 20260831
- Center classification date
- 20260915
- Report date
- 20260923
- Code info
- Lot # AD48154, Exp: 4/30/2027.
- Product description
Lidocaine Ointment USP, 5%, Speermint Flavor, 50 g Jar, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, L6T1C, Canada, Dist By: Taro Pharmaceuticals U.S.A. Inc. Hawthorne NY 70532 NDC: 51672-3008-5
- Harmonized identifiers (openFDA)
- Application number
- ANDA086724
- Brand name
- LIDOCAINE
- Generic name
- LIDOCAINE
- Manufacturer name
- Sun Pharmaceutical Industries, Inc.
- Product NDC
- 51672-3008
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- TOPICAL
- Substance name
- LIDOCAINE
- RxCUI
- 1543069
- SPL ID
- 5353eb70-1eeb-5479-e063-6394a90a2e2b
- SPL set ID
- 5eb2c62f-5352-41d7-bd66-c65b1988a9ab
- Package NDC
- 51672-3008-5, 51672-3008-3
- Is original packager
- true
- Nui
- N0000175682, M0000897, N0000175426, N0000175976
- Pharm class epc
- Amide Local Anesthetic [EPC], Antiarrhythmic [EPC]
- Pharm class cs
- Amides [CS]
- Pharm class pe
- Local Anesthesia [PE]
- UNII
- 98PI200987