FDA Recall
Terminated
Historical recordClass III
Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%, 15 gram tubes, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Village: Kishanpura, Baddi Nalagarth Road, District: Solan, Himachal Pradesh-173205, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-298-17
by Glenmark Pharmaceuticals Inc., USA
- Reason
- Temperature Abuse: Complaints received of liquidy texture.
- Published
- August 21, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
CRYO-273 Cold Pain Relieving Gel 128 FL. OZ. Distributed By: CRYO-273.com Tampa, FL 33629. UPC 8 15290 01550 2
by US Pharmaceuticals Inc.
- Reason
- CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
- Published
- August 21, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Wonder Freeze Pain Releiving Gel with ILEX, Menthol 5%, packaged in a) 3 OZ /85 g (UPC 0 99528 35903 5); b) 4 OZ / 113 g (UPC 0 99528 31504 8); c) 16 OZ / 454 g (UPC 0 99528 31516 1); Manufactured For: Wonder Laboratories, 115 S.C.T. Ct., White House TN. 37188.
by US Pharmaceuticals Inc.
- Reason
- CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
- Published
- August 21, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Kool Comfort Cooling Pain Relief, 5% Menthol, Packaged in a) 3 OZ./85 g (UPC 0 52301 35903 5); b) 4 OZ/ 113 g (UPC 0 52301 36504 3); c) 32 OZ/ 907 g (UPC 0 52301 36532 6); d) 16 OZ/ 454 g (UPC 0 52301 36516 6); e) 128 OZ/ 3629 g (UPC 0 52301 36512 8) Manufactured for: Dee Cee Laboratories, Inc. 304 Dee Cee Rd., White House, TN 37188.
by US Pharmaceuticals Inc.
- Reason
- CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
- Published
- August 21, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Cool Hot Ice Analgesic Gel, 8 oz (227 g) Distributed by: Unipack Inc. Pittsburg, PA 15239, USA. UPC 7 51393 00608 6
by US Pharmaceuticals Inc.
- Reason
- CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
- Published
- August 21, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
CRYO-273 Cold Pain Relieving Gel Roll-On 3 FL. OZ. (89 mL) Distributed By: CRYO-273.com Tampa, FL 33629. UPC 8 15290 01529 6
by US Pharmaceuticals Inc.
- Reason
- CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
- Published
- August 21, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
CVS Health Glycerin Suppositories, 100- count box, Distributed by:Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895. UPC 0 50428 42738 5
by US Pharmaceuticals Inc.
- Reason
- CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
- Published
- August 21, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Soothe&Cool Protect Moisture Guard Skin Protectant, 3.5 oz. (99 g), tube, Manufactured for Medline industries, Inc., Mundelein, IL 60060. NDC 53329-303-22
by US Pharmaceuticals Inc.
- Reason
- CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
- Published
- August 21, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Hydrocortisone Cream, Hydrocortisone 1% / Anti-Itch Cream, 2 OZ (56 g) tube. Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC #0363-0638-04, UPC 3 11917 18247 6
by US Pharmaceuticals Inc.
- Reason
- CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
- Published
- August 21, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Hydrocortisone Cream, Hydrocortisone 1% / Anti-Itch Cream, 1 OZ (28 g) tube. Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC #0363-0638-03, UPC 3 11917 18245 2 .
by US Pharmaceuticals Inc.
- Reason
- CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
- Published
- August 21, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Hydrocortisone Cream With Aloe, Hydrocortisone 1% / Anti-Itch Cream with Aloe, 2 OZ (56 g) tube. Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC #0363-0620-04, UPC 3 11917 17934 6
by US Pharmaceuticals Inc.
- Reason
- CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
- Published
- August 21, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Hydrocortisone Cream With Aloe, Hydrocortisone 1% / Anti-Itch Cream with Aloe, 1 OZ (28 g) tube. Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC #0363-0620-03, UPC 3 11917 17935 3
by US Pharmaceuticals Inc.
- Reason
- CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
- Published
- August 21, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Adult Glycerin Suppositories, Package Size 100-count suppositories, Distributed By: Walgreen Co. 200 Wilmot Rd. Deerfield, IL 60015. NDC#0363-0441-00
by US Pharmaceuticals Inc.
- Reason
- CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
- Published
- August 21, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Adult Glycerin Suppositories, Package Size 50-count suppositories, Distributed By: Walgreen Co. 200 Wilmot Rd. Deerfield, IL 60015. NDC#0363-0441-50
by US Pharmaceuticals Inc.
- Reason
- CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
- Published
- August 21, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Adult Glycerin Suppositories, Package Size 25-count suppositories, Distributed By: Walgreen Co. 200 Wilmot Rd. Deerfield, IL 60015. NDC#0363-0445-25,
by US Pharmaceuticals Inc.
- Reason
- CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
- Published
- August 21, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Children Glycerin Suppositories Laxative for ages 2 to 5. Package Size 25-count.Distributed by Walgreen CO. 200 Wilmot Rd. Deerfield IL 60015. NDC#0363-0440-25,
by US Pharmaceuticals Inc.
- Reason
- CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
- Published
- August 21, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
CVS Therapeutic Menthol Gel, 8 FL OZ (227 g) Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895. UPC 0 50428 48136 3
by US Pharmaceuticals Inc.
- Reason
- CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
- Published
- August 21, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Eczema Lotion Hydrocortisone 1% / Anti-Itch Lotion, 3.5 oz (99.2 g) Distributed By: Walgreen Co. 200 Wilmot Rd. Deerfield, IL,60015. NDC 0363-0670-04, UPC 3 11917 19308 3
by US Pharmaceuticals Inc.
- Reason
- CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
- Published
- August 21, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
CVS Health Glycerin Suppositories, 50-count box, Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895. UPC 0 50428 33106 4
by US Pharmaceuticals Inc.
- Reason
- CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
- Published
- August 21, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Macrobid Urinary Tract Anitbacterial, 100 mg, 100-count bottle, Rx Only, Mfg. by: Norwich Pharmaceuticals, Inc. Norwich, NY 13815 USA Dist. by: Almatica Pharma, Inc. Pine Brook, NJ 07058 USA, NDC 52427-285-01
by Alvogen, Inc
- Reason
- Failed dissolution specifications
- Published
- August 21, 2019
- Distribution
- Natonwide, PR
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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