Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 42582-113-10) and b) 500 tablet (NDC 42582-113-18) bottles, Rx, Distributed by; Bi-Coastal Pharma International, Shrewsbury, NJ, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India
Reported: May 2, 2018 Initiated: January 11, 2018 #D-0693-2018
Product Description
Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 42582-113-10) and b) 500 tablet (NDC 42582-113-18) bottles, Rx, Distributed by; Bi-Coastal Pharma International, Shrewsbury, NJ, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India
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 800 mg, a) 100 tablet (NDC 42582-113-10) and b) 500 tablet (NDC 42582-113-18) bottles, Rx, Distributed by; Bi-Coastal Pharma International, Shrewsbury, NJ, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India. 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-0693-2018.
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