Product Safety Recalls

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LIDOCAINE Recall D-0705-2022

Description: 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.

LIDOCAINE Recall D-0705-2022 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0705-2022
Event ID89798
Original Package?1
Active SubstanceLIDOCAINE
DistributionNationwide in the USA and Puerto Rico
Quantity49,081 tubes
Recall ReasoncGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Drug ClassificationClass II
Drug Code Info20220330
Product NDC50383-341
Product NUIN0000175682 M0000897 N0000175426
Pharma Class (PE)Local Anesthesia [PE]
Pharma Class (EPC)Amide Local Anesthetic [EPC]
Pharma Class (CS)Amides [CS]
Recall Initiation Date20220315
Report Date20220330
Classification Date20220321
Address105 Lincoln Avenue
Buena, NJ 08310
United States
Recalling FirmTeligent Pharma, Inc.
Initial Notification Letter
Unique Ingredient Identifier98PI200987
Drug Application NumberANDA205318
Structured Product Labeling (SPL ID)148d00de-9bbf-4528-8b9f-23a6274a24e7
Structured Product Labeling (SPL Set ID)f9303361-534d-4daa-bb4f-29992a0232dc
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