Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 42582-112-01), b) 500 tablet bottles (NDC 42582-112-18), Rx, Distributed by Drug Mart, Food Fair, Medina, Ohio 44256
Reported: May 2, 2018 Initiated: January 11, 2018 #D-0691-2018
Product Description
Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 42582-112-01), b) 500 tablet bottles (NDC 42582-112-18), Rx, Distributed by Drug Mart, Food Fair, Medina, Ohio 44256
Reason for Recall
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Details
- Recalling Firm
- Time-Cap Laboratories, Inc.
- Units Affected
- N/A
- Distribution
- Nationwide.
- Location
- Farmingdale, NY
Frequently Asked Questions
What product was recalled? ▼
Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 42582-112-01), b) 500 tablet bottles (NDC 42582-112-18), Rx, Distributed by Drug Mart, Food Fair, Medina, Ohio 44256. Recalled by Time-Cap Laboratories, Inc.. Units affected: N/A.
Why was this product recalled? ▼
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 2, 2018. Severity: Moderate. Recall number: D-0691-2018.
Related Recalls
CPSC Moderate
Meijer Recalls Lullaby Lane and MCS Children's Sleepwear Due to Burn Hazard; Violates Mandatory Standard for Children's…
· 2026-02-19
FDA Food Moderate
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Passion Fruit- UPC# 5061033691882
Diva Fam Inc · 2026-02-11
FDA Food Moderate
Repackaged M&Ms candies, Net Wt 1.3 oz. Item BB458BG. Labeled with the following promotional company names. 1. Nex…
Beacon Promotions Inc · 2026-02-11
FDA Food Critical
Sofit, Seedless Red Dates, 12 oz package, Plastic bags, 50 packages per case
Tai Phat Wholesalers, LLC · 2026-02-11
FDA Food Moderate
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Wildcrafted- UPC# 5065006235073
Diva Fam Inc · 2026-02-11