Class II
Terminated
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.
This recall has been terminated (originally issued March 30, 2022).
- Company
- Teligent Pharma, Inc.
- Recall Initiated
- March 15, 2022
- Posted
- March 30, 2022
- Recall Number
- D-0687-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 43,956 tubes
- Firm Location
- Buena, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Distribution
Nationwide in the USA and Puerto Rico
Lot / Code Info
Batch: a) 16878, 16912, Exp. 5/31/2023; b)16878, Exp. 5/21/2023
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