Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15), b) 30 g tubes (NDC 0713-0638-31), and c) 90 g tubes (NDC 0713-0638-18), Rx only, Manufactured by: G&W Laboratories, Inc., South Plainfeld, NJ 07080.
Reported: April 12, 2017 Initiated: March 20, 2017 #D-0636-2017
Product Description
Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15), b) 30 g tubes (NDC 0713-0638-31), and c) 90 g tubes (NDC 0713-0638-18), Rx only, Manufactured by: G&W Laboratories, Inc., South Plainfeld, NJ 07080.
Reason for Recall
Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.
Details
- Recalling Firm
- G & W Laboratories, Inc.
- Units Affected
- 230,700 tubes
- Distribution
- Nationwide in the USA and Puerto Rico
- Location
- South Plainfield, NJ
Frequently Asked Questions
What product was recalled? ▼
Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15), b) 30 g tubes (NDC 0713-0638-31), and c) 90 g tubes (NDC 0713-0638-18), Rx only, Manufactured by: G&W Laboratories, Inc., South Plainfeld, NJ 07080.. Recalled by G & W Laboratories, Inc.. Units affected: 230,700 tubes.
Why was this product recalled? ▼
Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 12, 2017. Severity: Low. Recall number: D-0636-2017.
Related Recalls
CPSC Moderate
Watkins Manufacturing Recalls Hydromassage Rotary Jets in Highlife Collection Spas Due to Entanglement and Drowning Haz…
· 2026-02-12
FDA Drug Moderate
Toothpaste: a) COLGATE, TOOTHPASTE, WHITENING, 2.5oz, 24ct; UPC: 035000511065; b) COLGATE, TOOTHPASTE, Regular, 2.5oz, …
GOLD STAR DISTRIBUTION INC · 2026-01-21
FDA Drug Moderate
Deodorant: a) Axe, Body Spray, Wild Spice, 6CT, 150ML, UPC: 600108736469; b) LUCKY MENS STICK DEODORANT, SPRING FRESH, …
GOLD STAR DISTRIBUTION INC · 2026-01-21
FDA Drug Moderate
ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs, LLC, Scottsdale, Arizona USA
Signature Formulations, LLC · 2026-01-14
FDA Food Moderate
Lava Bun with Green Tea Flavor bright lime green packaging (Frozen) Unsalted butter and cream are listed in the ingr…
Prime Food Processing LLC. · 2025-12-10