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Showing 6,601–6,620 of 17,964 drug recalls
Drug RecallTerminatedHistorical recordClass II
BAC 150 mcg/BUP 2 mg/Hydrom 15 mg/Morp 20 mg/SUF 650 mcg/mL Inj. in 20 mL syringe Assurance Infusion (713)533-8800
Sumatriptan Succinate Tablets, 50 mg, packaged in a) 9 (1x9) Unit-of use blister card (NDC 62756-521-69) and b) 100 count bottles, (NDC 62756-521-88), Rx only, Sun Pharma, Cranbury, NJ
by Sun Pharmaceutical Industries, Inc.
Reason
Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
Recall initiated
December 26, 2019
Reported by FDA
January 22, 2020
Distribution
Product was distributed throughout the United States to 96 distributors and 1 repacker/relabeler.
Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL Single Dose Vials (NDC 0641-6043-01), 25 vials/shelf-pack (NDC 0641-6043-25), For IM Use Only, Rx only, Manufactured by: WEST-WARD Eatontown, NJ 07724 USA.
by Hikma Pharmaceuticals USA Inc.
Reason
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Panther Platinum 30000 Capsules, in green, black background with white, red text in hologram paper packaging, packaged in 2, 4, and 10 count blister cards, Motto International, Dallas, TX
by Motto International Corp
Reason
Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
Rhino 7 Platinum 30000 Capsules, in blue,orange,black background with red,white,blue,gray text in hologram paper packaging, packaged in 2, 4, and 10 count blister cards, Motto International, Dallas, TX
by Motto International Corp
Reason
Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
Stallion Platinum 30000 Capsules in blue,orange,white background with red,white text in hologram paper packaging, packaged in 2, 4, 10 count blister cards, Motto International, Dallas, TX
by Motto International Corp
Reason
Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace
does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice --
always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take.
Read the full medical disclaimer.
