FDAFDA · Food and drugs·Recall number D-0693-2022
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.
Published March 30, 2022 · Recall initiated: March 15, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Teligent Pharma, Inc.
- Distributor
- Nationwide in the USA and Puerto Rico
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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