FDA Recall
TerminatedTerminated: June 17, 2024Historical recordClass II
Fluocinonide Gel USP, 0.05%, packaged in a) 15 g tubes, NDC 52565-054-15; b) 60 g tubes, NDC 52565-054-60; c) 30 g tubes, NDC 52565-054-30, 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
Fluocinonide Cream USP, 0.1%, 120 grams tube, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-079-11.
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
Econazole Nitrate Cream, 1%, packaged in a) 15 grams tubes, NDC 52565-022-15; b) 85 grams tubes, NDC 52565-022-85; c) 30 grams tubes, NDC 52565-022-30, 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
Diflorasone Diacetate Ointment USP, 0.05%, Net Wt 60 g tubes, Rx only, Manufactured for: SOLA Pharmaceuticals, LLC Baton Rouge, LA 70809, NDC 70512-031-60.
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
Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottles, Rx Only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70810, NDC 70512-025-05.
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
Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottle, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-002-05.
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
Desoximetasone Ointment USP, 0.25%, packaged in a) 100 grams tubes, NDC 52565-030-99; b) 60 grams tubes, NDC 52565-030-60; c) 15 grams tubes, NDC 52565-030-15, Rx Only, 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
Desoximetasone Ointment USP, 0.05%, packaged in a) 100 grams tubes, NDC 52565-045-99; b) 60 grams tubes, NDC 52565-045-60, 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
Desoximetasone Ointment USP, 0.05%, Net Wt. 100 grams tubes, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70810, NDC 70512-037-10.
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
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 →
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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