FDA event 89798 · Recall Observatory

drug · product 1 of 37

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

D-0669-2022

Recall number: D-0669-2022
Initiated: March 15, 2022
Classification: Class II
Status: Terminated
Recalling firm: Teligent Pharma, Inc.
Quantity: 43,218 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Code information

Batch: a) 15998, Exp. 3/31/2022; b) 16104, Exp. 4/30/2022; 16133, Exp. 5/31/2022; 16391, Exp. 8/31/2022; 15440, Exp. 9/30/2022

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 2 of 37

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.

D-0670-2022

Recall number: D-0670-2022
Initiated: March 15, 2022
Classification: Class II
Status: Terminated
Recalling firm: Teligent Pharma, Inc.
Quantity: 207,933 tubes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Code information

Batch: a) 15803, Exp. 7/31/2022; 16237, Exp. 11/30/2022; b) 15803, Exp. 7/31/2022; 16388, Exp. 2/28/2023; c) 15605, Exp. 7/31/2022; 16237, Exp. 11/30/2022; 16388, Exp. 2/28/2023; d) 15605, Exp. 7/31/2022; 15860, Exp. 8/31/2022; 16001, Exp. 9/30/2022; 16237, Exp. 11/30/2022; 16344, Exp. 1/31/2023; 16294, Exp. 2/28/2023; 16474, Exp. 2/28/2023; 16543, Exp. 2/28/2023.

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 3 of 37

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.

D-0671-2022

Recall number: D-0671-2022
Initiated: March 15, 2022
Classification: Class II
Status: Terminated
Recalling firm: Teligent Pharma, Inc.
Quantity: 105,200 tubes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Code information

Batch: a) 15377, Exp. 3/31/2022; 15927, Exp. 9/30/2022; 16130, Exp. 11/30/2022; b) 15117, Exp. 2/28/2022; 16028, Exp. 9/30/2022; 16945, Exp. 5/31/2023; c) 15377, Exp. 3/31/2022; 15927, Exp. 9/30/2022; 16683, Exp. 5/31/2022; d) 15116, Exp. 2/28/2022; 15117, Exp. 2/28/2022; 16130, Exp. 11/30/2022; 16228, Exp. 11/30/2022; 16348, Exp. 1/31/2023

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 4 of 37

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.

D-0672-2022

Recall number: D-0672-2022
Initiated: March 15, 2022
Classification: Class II
Status: Terminated
Recalling firm: Teligent Pharma, Inc.
Quantity: 35,180 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Code information

Batch: a) 15599, Exp. 4/30/2022; 16108, Exp. 10/31/2022; 16471, Exp. 2/28/2023; 16680, Exp. 3/31/2023; b) 15120, 15126, 15592, Exp. 2/28/2022; 15599, Exp. 4/30/2022; 16108, 16145, Exp. 10/31/2022; 16261, Exp. 12/31/2022; 16456, 16471, Exp. 2/28/2023; 16552, 16680, Exp. 3/31/2023

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 5 of 37

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.

D-0673-2022

Recall number: D-0673-2022
Initiated: March 15, 2022
Classification: Class II
Status: Terminated
Recalling firm: Teligent Pharma, Inc.
Quantity: 72,826 tubes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Code information

Batch: a) 15856, Exp. 8/31/2022; 17026, Exp. 6/30/2023; b) 15856, Exp. 8/31/2022; 17026, Exp. 6/30/2023; 17046, Exp. 6/30/2023; c) 15856, Exp. 8/31/2022; d) 15856, Exp. 8/31/2022; 17026, Exp. 6/30/2023

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 6 of 37

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.

D-0674-2022

Recall number: D-0674-2022
Initiated: March 15, 2022
Classification: Class II
Status: Terminated
Recalling firm: Teligent Pharma, Inc.
Quantity: 81,883 tubes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Code information

Batch: a) 15063, Exp. 2/28/2022; 15928, Exp. 9/30/2022; 16432, Exp. 2/28/2023; 16769, Exp. 4/30/2023; b) 15243, Exp. 2/28/2022; 16628, Exp. 3/31/2023; c) 15064, 15286, 15287, Exp. 2/28/2022; 16173, Exp. 11/30/2022; 16628, Exp. 3/31/2023

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 7 of 37

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.

D-0675-2022

Recall number: D-0675-2022
Initiated: March 15, 2022
Classification: Class II
Status: Terminated
Recalling firm: Teligent Pharma, Inc.
Quantity: 36,426 tubes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Code information

Batch: a) 15495, Exp. 4/30/2022; 16955, Exp. 5/31/2023; b) 15249, 15250, 15446, Exp. 3/31/2022; 15495, Exp. 4/30/2022; 16377, Exp. 1/31/2023

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 8 of 37

Desoximetasone Ointment USP, 0.05%, Net Wt. 100 grams tubes, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70810, NDC 70512-037-10.

D-0676-2022

Recall number: D-0676-2022
Initiated: March 15, 2022
Classification: Class II
Status: Terminated
Recalling firm: Teligent Pharma, Inc.
Quantity: 6850 tubes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Code information

Batch: 15996, 15997, Exp. 9/30/2022

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 9 of 37

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.

D-0677-2022

Recall number: D-0677-2022
Initiated: March 15, 2022
Classification: Class II
Status: Terminated
Recalling firm: Teligent Pharma, Inc.
Quantity: 54,897 tubes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Code information

Batch: a) 15196, Exp. 2/28/2022; 16605, Exp. 3/31/2023; b)15190, Exp. 2/28/2022; 16660, Exp. 4/30/2023; 17037, Exp. 6/30/2023; 17163, Exp. 8/31/2023

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 10 of 37

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.

D-0678-2022

Recall number: D-0678-2022
Initiated: March 15, 2022
Classification: Class II
Status: Terminated
Recalling firm: Teligent Pharma, Inc.
Quantity: 13,989 tubes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Code information

Batch: a) 15496, Exp. 4/30/2022; 16347, Exp. 1/31/2023; b) 15496, Exp. 4/30/2022; 16298, Exp. 1/31/2023; c) 15496, Exp. 4/30/2022; 16298, Exp. 1/31/2023

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 11 of 37

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.

D-0679-2022

Recall number: D-0679-2022
Initiated: March 15, 2022
Classification: Class II
Status: Terminated
Recalling firm: Teligent Pharma, Inc.
Quantity: 16,643 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Code information

Batch: 15066, 15389 Exp. 3/31/2023; 15437, Exp. 12/31/2023; 16823, Exp. 4/30/2024; 16825, 16826, Exp. 4/30/2024

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 12 of 37

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.

D-0680-2022

Recall number: D-0680-2022
Initiated: March 15, 2022
Classification: Class II
Status: Terminated
Recalling firm: Teligent Pharma, Inc.
Quantity: 36,018 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Code information

Batch: 15384, Exp. 3/31/2023; 15646, Exp. 5/31/2023; 15971, Exp. 9/30/2023; 16206, 16226, Exp. 11/30/2023; 16268, Exp. 12/31/2023; 16342, 16343, Exp. 1/31/2024; 16503, 16504, Exp. 3/31/2024; 16632, Exp. 4/30/2024; 16715, 16731, Exp. 5/31/2024

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 13 of 37

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.

D-0681-2022

Recall number: D-0681-2022
Initiated: March 15, 2022
Classification: Class II
Status: Terminated
Recalling firm: Teligent Pharma, Inc.
Quantity: 24,304 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Code information

Batch: 15800, Exp. 7/31/2022; 15876, 15904, 15917, 15922, Exp. 8/31/2022; 16202, 16203, Exp. 11/30/2022.

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 14 of 37

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.

D-0682-2022

Recall number: D-0682-2022
Initiated: March 15, 2022
Classification: Class II
Status: Terminated
Recalling firm: Teligent Pharma, Inc.
Quantity: 151,975 tubes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Code information

Batch: a) 16410, 16438, Exp. 1/31/2023; 16882, Exp. 4/30/2023; b) 15349, Exp. 2/28/2022; 16410, 16438, Exp. 1/31/2023; 16882, Exp. 4/30/2023; c) 16410, 16438, Exp. 1/31/2023

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 15 of 37

Fluocinonide Cream USP, 0.1%, 120 grams tube, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-079-11.

D-0683-2022

Recall number: D-0683-2022
Initiated: March 15, 2022
Classification: Class II
Status: Terminated
Recalling firm: Teligent Pharma, Inc.
Quantity: 13,905 tubes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Code information

Batch: 15288, Exp. 3/31/2022; 16065, Exp. 10/31/2022; 16430, 16431, Exp. 2/28/2023; 16675, Exp. 3/31/2023

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 16 of 37

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.

D-0684-2022

Recall number: D-0684-2022
Initiated: March 15, 2022
Classification: Class II
Status: Terminated
Recalling firm: Teligent Pharma, Inc.
Quantity: 51,748 tubes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Code information

Batch: a) 15122, Exp. 2/28/2022; 15475, Exp. 3/31/2022; b) 15119, Exp. 2/28/2022; 15122, Exp. 2/28/2022; 15380, Exp. 3/31/2022; c) 15380, Exp. 3/31/2022

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 17 of 37

Fluocinonide Topical Solution USP, 0.05%, packaged in a) 20 mL bottles, NDC 52565-025-20; b) 60 mL bottles, NDC 52565-025-59, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310.

D-0685-2022

Recall number: D-0685-2022
Initiated: March 15, 2022
Classification: Class II
Status: Terminated
Recalling firm: Teligent Pharma, Inc.
Quantity: 7169 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Code information

Batch: 17138, Exp. 2/28/2023

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 18 of 37

Gentamicin Sulfate Cream USP, 0.1%, packaged in a) 15 g tubes, NDC 52565-085-15, b) 30 g tubes, NDC 52565-085-30, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.

D-0686-2022

Recall number: D-0686-2022
Initiated: March 15, 2022
Classification: Class II
Status: Terminated
Recalling firm: Teligent Pharma, Inc.
Quantity: 355,672 tubes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Code information

Batch: a) 15342, 15343, 16686, Exp. 3/31/2023; b) 15259, 15260, Exp. 3/31/2022; 15282, Exp. 4/30/2022; 15283, Exp. 5/31/2022; 15725, 15745, 15764, Exp. 6/30/2022; 16066, Exp. 10/31/2022

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 19 of 37

Gentamicin Sulfate Ointment USP 0.1%, packaged as a) 15 grams tube, NDC 52565-090-15; b) 30 grams tube, NDC 52565-090-30, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.

D-0687-2022

Recall number: D-0687-2022
Initiated: March 15, 2022
Classification: Class II
Status: Terminated
Recalling firm: Teligent Pharma, Inc.
Quantity: 43,956 tubes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Code information

Batch: a) 16878, 16912, Exp. 5/31/2023; b)16878, Exp. 5/21/2023

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 20 of 37

Halobetasol Propionate Ointment, 0.05%, Net Wt. 50 grams tube, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70809, NDC 70512-033-50.

D-0688-2022

Recall number: D-0688-2022
Initiated: March 15, 2022
Classification: Class II
Status: Terminated
Recalling firm: Teligent Pharma, Inc.
Quantity: 35,185 tubes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Code information

Batch: 15128, Exp. 2/28/2022; 15721, Exp. 6/30/2022; 16171, Exp. 10/31/2022; 16819, Exp. 4/30/2023; 17124, Exp. 7/31/2023

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 21 of 37

Halobetasol Propionate Ointment, 0.05%, packaged as a) 15 g tubes, NDC 52565-073-15; b) 50 g tubes, NDC 52565-073-51, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.

D-0689-2022

Recall number: D-0689-2022
Initiated: March 15, 2022
Classification: Class II
Status: Terminated
Recalling firm: Teligent Pharma, Inc.
Quantity: 161,331 tubes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Code information

Batch: a) 15280, Exp. 2/28/2022; 16539, Exp. 3/31/2023; 16907, Exp. 5/31/2023; b) 15381, Exp. 3/31/2022; 15382, 15501, 15523, Exp. 4/30/2022; 15812, Exp. 7/31/2022; 15972, 16034, 16037, Exp. 9/30/2022; 16105, 16143, Exp. 10/31/2022; 16539, 16746, 16747, Exp. 3/31/2023; 16906, Exp. 5/31/2023; 16962, 17041, Exp. 6/30/2023; 17110, Exp. 7/31/2023

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 22 of 37

Hydrocortisone Butyrate Lotion 0.1%, 4 fl. oz. (118 mL) bottle, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-159-04.

D-0690-2022

Recall number: D-0690-2022
Initiated: March 15, 2022
Classification: Class II
Status: Terminated
Recalling firm: Teligent Pharma, Inc.
Quantity: 6431 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Code information

Batch: 15435, Exp. 3/31/2022; 16960, Exp. 5/31/2023

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 23 of 37

Halobetasol Propionate Ointment, 0.05%, Net Wt. 50 grams tube, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation, dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-998-67.

D-0691-2022

Recall number: D-0691-2022
Initiated: March 15, 2022
Classification: Class II
Status: Terminated
Recalling firm: Teligent Pharma, Inc.
Quantity: 21,323 tubes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Code information

Batch: 15720, Exp. 6/30/2022; 16449, 16450, Exp. 2/28/2023

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 24 of 37

Hydrocortisone Butyrate Lotion, 0.1%, packaged in a) 2 fl oz (59 mL) bottles, NDC 52565-087-02; b) 4 fl oz (118 mL) bottles, NDC 52565-087-04, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.

D-0692-2022

Recall number: D-0692-2022
Initiated: March 15, 2022
Classification: Class II
Status: Terminated
Recalling firm: Teligent Pharma, Inc.
Quantity: 30,497 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Code information

Batch: a) 16293, Exp. 1/31/2023; 16436, 16451, Exp. 2/28/2023; b) 15105, Exp. 2/28/2022; 15290, 15291, 15292, Exp. 3/31/2022; 16293, Exp. 1/31/2023; 16436, 16451, 16472, Exp. 2/28/2023

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 25 of 37

Lidocaine Cream, 4%, packaged in a) Net Wt. 15 grams tubes, NDC 52565-122-15; b) Net Wt. 30 grams tubes, NDC 52565-122-30; c) 5 x 5 gram tubes, NDC 52565-122-07; Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310; Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310.

D-0693-2022

Recall number: D-0693-2022
Initiated: March 15, 2022
Classification: Class II
Status: Terminated
Recalling firm: Teligent Pharma, Inc.
Quantity: 136,960 tubes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Code information

Batch: a) 15192, Exp. 2/28/2022; 16278, Exp. 1/31/2023; b) 15124, 15192, Exp. 2/28/2022; 15296, 15336, 15337, 15439, Exp. 3/31/2022; 16278, Exp. 1/31/2023; 16603, 16664, Exp. 3/31/2023;17023, Exp. 6/30/2023; c) 15067, Exp. 2/28/2022; 16664, Exp. 3/31/2023

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 26 of 37

Lidocaine Ointment USP, 5%, Net Wt 35.44 g (1 1/4 oz) tube, Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-008-14.

D-0694-2022

Recall number: D-0694-2022
Initiated: March 15, 2022
Classification: Class II
Status: Terminated
Recalling firm: Teligent Pharma, Inc.
Quantity: 100,256 tubes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Code information

Batch: 16389, Exp. 2/29/2024; 16452, Exp. 2/29/2024

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 27 of 37

Nystatin and Triamcinolone Acetonide Ointment, USP, packaged in a) 15 grams tubes, NDC 52565-042-15; b) 30 grams tubes, NDC 52565-042-30; c) 60 grams tubes, NDC 52565-042-60, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.

D-0695-2022

Recall number: D-0695-2022
Initiated: March 15, 2022
Classification: Class II
Status: Terminated
Recalling firm: Teligent Pharma, Inc.
Quantity: 217,184 tubes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Code information

Batch: a) 15125, Exp. 2/28/2022; 15385, Exp. 3/31/2022; 15613, Exp. 5/31/2022; 16027, Exp. 9/30/2022; 16204, Exp. 11/30/2022; 16376, Exp. 1/31/2023; 16707, Exp. 3/31/2023; b) 15385, Exp. 3/31/2022; 15752, Exp. 6/30/2022; 15346, Exp. 9/30/2022; 16188, Exp. 11/30/2022; 16567, Exp. 2/28/2023; 16730, Exp. 4/30/2023; c)15752, Exp. 6/30/2022; 16188, Exp. 11/30/2022

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 28 of 37

Triamcinolone Acetonide Ointment USP, 0.5%, Net Wt. 15 grams tube, Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-048-15.

D-0696-2022

Recall number: D-0696-2022
Initiated: March 15, 2022
Classification: Class II
Status: Terminated
Recalling firm: Teligent Pharma, Inc.
Quantity: 159,994 tubes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Code information

Batch: 15608, Exp. 5/31/2022; 16026, Exp. 9/30/2022; 16224, Exp. 11/30/2022

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 29 of 37

Triamcinolone Acetonide Cream USP, 0.1%, packaged in a) 15 grams tubes, NDC 52565-056-15; b) 30 grams tubes, NDC 52565-056-30; c) 80 grams tubes, NDC 52565-056-80, d) 1 lb (454 g) jars, NDC 52565-056-26; Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310.

D-0697-2022

Recall number: D-0697-2022
Initiated: March 15, 2022
Classification: Class II
Status: Terminated
Recalling firm: Teligent Pharma, Inc.
Quantity: 721,225 tubes; 90,893 jars

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Code information

Batch: a) 15123, Exp. 2/28/2022; 15875, Exp. 8/31/2022; 16115, Exp. 10/31/2022; b) 15123, 15201, Exp. 2/28/2022; 15477, Exp. 4/30/2022; 15897, Exp. 8/31/2022; 16090, Exp. 10/31/2022; 16374, Exp. 1/31/2023; 16676, Exp. 3/31/2023; 17109, Exp. 7/31/2023; c) 15241, Exp. 2/28/2022; 16610, Exp. 3/31/2023; d) 15121, 15127, 15191, 15201, 15278, Exp. 2/28/2022;15386, 15567, Exp. 4/30/2022; 15875, Exp. 8/31/2022; 16050, 16051, 16115, Exp. 10/31/2022; 16165, 16201, Exp. 11/30/2022; 16609, 16610, 16624, Exp. 3/31/2023; 16700, Exp. 4/30/2023; 16732, Exp. 5/31/2023; 17081, 17108, Exp. 7/31/2023

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 30 of 37

Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-010-59.

D-0698-2022

Recall number: D-0698-2022
Initiated: March 15, 2022
Classification: Class II
Status: Terminated
Recalling firm: Teligent Pharma, Inc.
Quantity: 112,769 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Code information

Batch: 14796, Exp. 12/31/2022; 14797, Exp. 1/31/2023; 14534, 15571, 15572, Exp. 4/30/2023; 15746, 15756, Exp. 6/30/2023; 15982, Exp. 9/30/2023; 16043, 16144, 16149, Exp. 10/31/2023; 16433, 16434, Exp. 2/29/2024; 16656, 16679, Exp. 3/31/2024; 16784, Exp. 5/31/2024

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 31 of 37

Triamcinolone Acetonide Ointment USP, 0.1%, packaged in a) 15 grams tubes, NDC 52565-014-15; b) 80 grams tubes, NDC 52565-014-80; c) 1 lb (454 g) jars, NDC 52565-014-26; Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310.

D-0699-2022

Recall number: D-0699-2022
Initiated: March 15, 2022
Classification: Class II
Status: Terminated
Recalling firm: Teligent Pharma, Inc.
Quantity: 482,003 tubes; 45,583 jars

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Code information

Batch: a) 15000, Exp. 1/31/2023; 15591, Exp. 4/30/2023; 15946, Exp. 9/30/2023; b) 14674, Exp. 11/30/2022; 14760, 14798, Exp. 12/31/2022; 14896, Exp. 1/31/2023; 15000, Exp. 1/31/2023; 15591, Exp. 4/30/2023; 15802, 15833, Exp. 7/31/2023; 15872, Exp. 8/31/2023; 15946, Exp. 9/30/2023; 16069, Exp. 10/31/2023; 16199, Exp. 11/30/2023; 16429, Exp. 2/29/2024; 16608, 16712, Exp. 3/31/2024; 17080, Exp. 7/31/2024; c)15065, Exp. 2/28/2023; 15072, Exp. 2/28/2023; 15436, Exp. 3/31/2023; 15810, Exp. 7/31/2023; 15877, Exp. 8/31/2023; 15974, Exp. 9/30/2023; 16045, Exp. 10/31/2023; 16269, Exp. 12/31/2023; 16270, Exp. 12/31/2023; 16566, Exp. 3/31/2024; 16713, Exp. 3/31/2024; 17042, Exp. 6/30/2024; 17068, Exp. 7/31/2024

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 32 of 37

Clobetasol Propionate Cream USP, 0.05%, packaged in 60 grams tube, Rx only, Manufactured for SOLA Pharmaceuticals, Baton Rouge, LA 70809; NDC 70512-028-60.

D-0700-2022

Recall number: D-0700-2022
Initiated: March 15, 2022
Classification: Class II
Status: Terminated
Recalling firm: Teligent Pharma, Inc.
Quantity: 26,326 tubes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Code information

Batch: 16001 Exp. 9/30/2022; 16089 Exp. 11/30/2022

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 33 of 37

Diflorasone Diacetate Ointment USP, 0.05%, Net Wt 60 g tubes, Rx only, Manufactured by: Teligent Pharm, Inc., Buena, New Jersey 08310, NDC 52565-063-60.

D-0701-2022

Recall number: D-0701-2022
Initiated: March 15, 2022
Classification: Class II
Status: Terminated
Recalling firm: Teligent Pharma, Inc.
Quantity: 4532 tubes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Code information

Batch: 15876, Exp 8/31/2022; 16205, Exp. 11/30/2022

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 34 of 37

Gentamicin Sulfate Cream USP, 0.1%, packaged in 30 grams tubes, Rx Only, Manufactured for: SOLA Pharmaceuticals, LLC, Baton Rouge, LA 70810, NDC 70512-036-30.

D-0702-2022

Recall number: D-0702-2022
Initiated: March 15, 2022
Classification: Class II
Status: Terminated
Recalling firm: Teligent Pharma, Inc.
Quantity: 31,489 tubes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Code information

Batch: 15725, Exp. 6/30/2022; 16113, Exp. 10/31/2022

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 35 of 37

Hydrocortisone Butyrate Lotion, 0.1%, 4 fl oz (118 mL) bottle, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70809, NDC 70512-032-04.

D-0703-2022

Recall number: D-0703-2022
Initiated: March 15, 2022
Classification: Class II
Status: Terminated
Recalling firm: Teligent Pharma, Inc.
Quantity: 6874 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Code information

Batch: 16896, 16897 Exp. 5/31/2023

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 36 of 37

Lidocaine Cream 4%, Net Wt. 30 grams tube, Distributed by: RUGBY LABORATORIES, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0536-1281-28.

D-0704-2022

Recall number: D-0704-2022
Initiated: March 15, 2022
Classification: Class II
Status: Terminated
Recalling firm: Teligent Pharma, Inc.
Quantity: 48,907 tubes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Code information

Batch: 15722, Exp. 6/30/2022; 16274, Exp. 12/31/2022; 16947, Exp. 5/31/2023; 17140, Exp. 8/31/2023

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 37 of 37

Lidocaine Ointment USP, 5%, Net Wt 35.44 g (1 1/4 Oz) tube, Rx Only, Manufactured for: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-341-35.

D-0705-2022

Recall number: D-0705-2022
Initiated: March 15, 2022
Classification: Class II
Status: Terminated
Recalling firm: Teligent Pharma, Inc.
Quantity: 49,081 tubes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Code information

Batch: 16695, Exp 4/30/2024

Distribution pattern

Nationwide in the USA and Puerto Rico

Event summary

Source snapshots represented here

Every recalled product in this event

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