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.
Reported: March 30, 2022 Initiated: March 15, 2022 #D-0705-2022
Product 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.
Reason for Recall
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Details
- Recalling Firm
- Teligent Pharma, Inc.
- Units Affected
- 49,081 tubes
- Distribution
- Nationwide in the USA and Puerto Rico
- Location
- Buena, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Teligent Pharma, Inc.. Units affected: 49,081 tubes.
Why was this product recalled? ▼
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 30, 2022. Severity: Moderate. Recall number: D-0705-2022.
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