FDA Recall
TerminatedTerminated: June 17, 2024Historical recordClass II
Desonide Ointment, 0.05%, packaged in a) 15 g tubes, NDC 52565-038-15; b) 60 g tubes, NDC 52565-038-60, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
by Teligent Pharma, Inc.
- Reason
- cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- Published
- March 30, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 17, 2024Historical recordClass II
Clobetasol Propionate Gel, 0.05%, packaged in a) 15 grams tube, NDC 52565-082-15; b) 30 grams tube, NDC 52565-082-30; c) 60 grams tube, NDC 52565-082-60, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310.
by Teligent Pharma, Inc.
- Reason
- cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- Published
- March 30, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 17, 2024Historical recordClass II
Clobetasol Propionate Ointment USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-039-15; b) 30 grams tube, NDC 52565-039-30; c) 45 grams tube, NDC 52565-039-45; d) 60 grams tube, NDC 52565-039-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
by Teligent Pharma, Inc.
- Reason
- cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- Published
- March 30, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 17, 2024Historical recordClass II
Clobetasol Propionate Lotion, 0.05%, packaged in a) 2 fl. oz. (59 mL) bottles, NDC 52565-055-02; b) 4 fl. oz. (118 mL) bottles, NDC 52565-055-04, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310.
by Teligent Pharma, Inc.
- Reason
- cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- Published
- March 30, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 17, 2024Historical recordClass II
Clobetasol Propionate Cream USP, 0.05% (Emollient), packaged in a) 15 grams tube, NDC 52565-094-15; b) 30 grams tube, NDC 52565-094-30; c) 45 grams tube, NDC 52565-094-45; d) 60 grams tube, NDC 52565-094-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
by Teligent Pharma, Inc.
- Reason
- cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- Published
- March 30, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 17, 2024Historical recordClass II
Clobetasol Propionate Cream USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-051-15; b) 30 grams tube, NDC 52565-051-30; c) 45 grams tube, NDC 52565-051-45; d) 60 grams tube, NDC 52565-051-60; Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
by Teligent Pharma, Inc.
- Reason
- cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- Published
- March 30, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 17, 2024Historical recordClass II
Betamethasone Dipropionate Lotion USP, 0.05%* (Augmented), packaged in a) 30 mL (29 grams) bottles, NDC 52565-023-29; b) 60 mL (58 grams) bottles, NDC 52565-023-59, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310
by Teligent Pharma, Inc.
- Reason
- cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- Published
- March 30, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: August 1, 2022Historical recordClass I
REVITADERM WOUND CARE GEL, (Benzalkonium Chloride in a gel containing transforming growth factor-b), 0.1%, packaged in 29.6 mL (1.0 FL OZ) bottles (NDC 63347-120-02) and 88.7 mL (3.0 FL OZ) tubes (NDC 63347-120-01), Blaine Labs Inc., Santa Fe Springs, CA 90670
by Blaine Labs Inc
- Reason
- Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.
- Published
- March 30, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 2, 2022Historical recordClass I
Avaphinal Maximum Male Enhancement Sexual Pills, 2000 MG*, packaged in 10 Capsules per carton.
by Walmart Stores
- Reason
- Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
- Published
- March 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 16, 2023Historical recordClass II
0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun Medical Inc., Bethlehem, PA, NDC 0264-7800-20
by B. Braun Medical, Inc.
- Reason
- Lack of sterility assurance: leaking bags
- Published
- March 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: July 16, 2023Historical recordClass II
hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152 USA. NDC # 0904-6440-61
by The Harvard Drug Group
- Reason
- Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.
- Published
- March 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: July 6, 2022Historical recordClass II
FDMR, INC DBA SUJI'S KOREAN CUISINE
- Product
- Taiyaki Variety Pack; 21.6 oz. (600g) 30 fish waffles in a…
- Reason
- Hazelnuts were declared in ingredient statement but not in Contains statement.
- Published
- March 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: June 14, 2022Historical recordClass II
Tony's Tejas Salsa
- Product
- Port City Soups Baton Rouge Beans 32oz glass mason jar so…
- Reason
- Production Process not approved for acidified foods.
- Published
- March 23, 2022
- Distribution
- Alabama, Louisiana, Mississippi, and Ten…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: June 14, 2022Historical recordClass II
Tony's Tejas Salsa
- Product
- Port City Soups Thai Green Curry 32oz glass mason jar sol…
- Reason
- Production Process not approved for acidified foods.
- Published
- March 23, 2022
- Distribution
- Alabama, Louisiana, Mississippi, and Ten…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: June 14, 2022Historical recordClass II
Tony's Tejas Salsa
- Product
- Port City Soups Alkaline Vegetable Soup 32oz glass mason j…
- Reason
- Production Process not approved for acidified foods.
- Published
- March 23, 2022
- Distribution
- Alabama, Louisiana, Mississippi, and Ten…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: June 14, 2022Historical recordClass II
Tony's Tejas Salsa
- Product
- Port City Soups Tex-Mex Chili 32oz glass mason jar sold b…
- Reason
- Production Process not approved for acidified foods.
- Published
- March 23, 2022
- Distribution
- Alabama, Louisiana, Mississippi, and Ten…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: June 14, 2022Historical recordClass II
Tony's Tejas Salsa
- Product
- Port City Soups Creole Gumbo 32oz glass mason jar sold by…
- Reason
- Production Process not approved for acidified foods.
- Published
- March 23, 2022
- Distribution
- Alabama, Louisiana, Mississippi, and Ten…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: October 19, 2022Historical recordClass III
PS Seasoning & Spices, Inc.
- Product
- WAP Honey BBQ Seasoning Net Wt 20.64 lbs. (9.36kg). Part…
- Reason
- Undeclared wheat.
- Published
- March 23, 2022
- Distribution
- AR, CO, CT, FL, GA, IA, ID, IL, IN, KS,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: October 19, 2022Historical recordClass III
PS Seasoning & Spices, Inc.
- Product
- Maplewood Meats Honey BBQ Stick Seasoning Net Wt 21 lbs.…
- Reason
- Undeclared wheat.
- Published
- March 23, 2022
- Distribution
- AR, CO, CT, FL, GA, IA, ID, IL, IN, KS,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: October 19, 2022Historical recordClass III
PS Seasoning & Spices, Inc.
- Product
- 796-B Honey Sriracha Snack Stick Seasoning Net Wt 5.25 l…
- Reason
- Undeclared wheat.
- Published
- March 23, 2022
- Distribution
- AR, CO, CT, FL, GA, IA, ID, IL, IN, KS,…
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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