Why it was recalled
GMP Deviations: Glenmark received complaints stating that mometasone fuorate cream was gritty.
Product description
Mometasone Furoate Cream USP, 0.1%, packaged in a) 15gram tubes (NDC 68462-192-17) and b) 45 gram tubes (NDC 68462-192-55), Rx Only, Manufactured by; Glenmark Pharmaceuticals Ltd At: Village: Kishanpura, Baddi Nalagari Road, District: Solan, Himachal Pradesh -173205, India Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
Lot numbers, UPCs & expiration codes
a) 05171238, 05171248, 05171249, Exp. Jul-2019; 05171582, 05171612, Exp. Aug-2019; 05171674, 05171675, 05171682, Exp. Sep 2019; 05180065, 05180066, Exp. Dec 2019; 05180264, 05180264, 05180265, 05180275, 0518276, Exp. Jan 2020; 05180411, 05180412, 05180422, Exp. Jan 2020; 05180556, 05180568 Exp..Feb-2020; 05180889, 05180890, 05180896, 05180896, 05180897 Exp. Apr 2020; 05181123, 05181129, 05181134, 05181135, Exp. May 2020; 05181415, 05181425, 05181429, 05181433, Exp. Jun 2020; 05181528, Exp. Jul 2020; 05181747, 05181748, Exp. Aug 2020. b) 05171207, 05171212, 05171213, 05171232, 05171233, Exp. Jul-2019; 05171476, 05171478, 05171479, Exp. Aug 2019; 05171596 , 05171597, 05171602, 05171603, Exp. Aug 2019; 05171683, 05171697, 05171698, 05171703, 05171718, 05171783, 05171788, 05171789, 05171790, 05171791, Exp. Sep 2019; 05180092, 05180093, 05180119, 05180219, 05180220, Exp. Dec 2019; 05180289, 05180291, 05180434,05180435, Exp. Jan-2020; 05180438, 05180439, 05180443, 05180444, 05180450, 05180462, 05180572, 05180646, Exp. Feb 2020 05180648, 05180649, 05180659, 05180660, 05180671, Mar 2020; 05180870, 05180871, 05180874, 05180877, 05180900, 05180901, Exp. Apr 2020; 05181073, 05181074, 05181086, 05181087, 05181091, 05181092, 05181101, 05181102, 05181111, 05181146, 05181147, 05181148, 05181240 Exp. May 2020; 05181241, 05181248, 05181252, 05181253, 05181257, 05181265, 05181266, 05181267, 05181272, 05181309, 05181316, 05181317, 05181332 Exp. Jun 2020; 05181588, 05181602, 05181603, 05181618, 05181619, 05181621, 05181622, 05181633, 05181634 Exp. Jul 2020; 05181754, 05181772, 05181773, 05181781 Exp. Aug 2020
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1586-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 23, 2019
- FDA report date
- Aug 14, 2019
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
Original FDA data
Every field from FDA enforcement report D-1586-2019, exactly as published.
Show all FDA fields
- City
- Mahwah
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 83413
- Address
- 750 Corporate Dr
- Code information
- a) 05171238, 05171248, 05171249, Exp. Jul-2019; 05171582, 05171612, Exp. Aug-2019; 05171674, 05171675, 05171682, Exp. Sep 2019; 05180065, 05180066, Exp. Dec 2019; 05180264, 05180264, 05180265, 05180275, 0518276, Exp. Jan 2020; 05180411, 05180412, 05180422, Exp. Jan 2020; 05180556, 05180568 Exp..Feb-2020; 05180889, 05180890, 05180896, 05180896, 05180897 Exp. Apr 2020; 05181123, 05181129, 05181134, 05181135, Exp. May 2020; 05181415, 05181425, 05181429, 05181433, Exp. Jun 2020; 05181528, Exp. Jul 2020; 05181747, 05181748, Exp. Aug 2020. b) 05171207, 05171212, 05171213, 05171232, 05171233, Exp. Jul-2019; 05171476, 05171478, 05171479, Exp. Aug 2019; 05171596 , 05171597, 05171602, 05171603, Exp. Aug 2019; 05171683, 05171697, 05171698, 05171703, 05171718, 05171783, 05171788, 05171789, 05171790, 05171791, Exp. Sep 2019; 05180092, 05180093, 05180119, 05180219, 05180220, Exp. Dec 2019; 05180289, 05180291, 05180434,05180435, Exp. Jan-2020; 05180438, 05180439, 05180443, 05180444, 05180450, 05180462, 05180572, 05180646, Exp. Feb 2020 05180648, 05180649, 05180659, 05180660, 05180671, Mar 2020; 05180870, 05180871, 05180874, 05180877, 05180900, 05180901, Exp. Apr 2020; 05181073, 05181074, 05181086, 05181087, 05181091, 05181092, 05181101, 05181102, 05181111, 05181146, 05181147, 05181148, 05181240 Exp. May 2020; 05181241, 05181248, 05181252, 05181253, 05181257, 05181265, 05181266, 05181267, 05181272, 05181309, 05181316, 05181317, 05181332 Exp. Jun 2020; 05181588, 05181602, 05181603, 05181618, 05181619, 05181621, 05181622, 05181633, 05181634 Exp. Jul 2020; 05181754, 05181772, 05181773, 05181781 Exp. Aug 2020
- Postal code
- 07430-2009
- Report date
- Aug 14, 2019
- Product type
- Drugs
- Recall number
- D-1586-2019
- Classification
- Class II
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Termination date
- Oct 26, 2021
- Reason for recall
- GMP Deviations: Glenmark received complaints stating that mometasone fuorate cream was gritty.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Mometasone Furoate Cream USP, 0.1%, packaged in a) 15gram tubes (NDC 68462-192-17) and b) 45 gram tubes (NDC 68462-192-55), Rx Only, Manufactured by; Glenmark Pharmaceuticals Ltd At: Village: Kishanpura, Baddi Nalagari Road, District: Solan, Himachal Pradesh -173205, India Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Jul 23, 2019
- Initial firm notification
- Letter
- Center classification date
- Aug 2, 2019