Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
Presence of Foreign Tablets/Capsules: One foreign tablet identified as Clopidogrel 75 mg was found in a 100 count bottle of Metoprolol Succiante Extended-Release Tablets.
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg
Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg contained Diclofenac Sodium and Misoprostol 50 mg/0.2 mg tablets.
Class II · Moderate risk
Sulfamethoxazole and Trimethoprim Tablets USP
Presence of Foreign Substance:Sun Pharma is recalling one (1) lot of Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg (500 ct.) because a foreign matter identified as polyethylene was detected in two (2) tablets.
Class II · Moderate risk
Fluocinolone Acetonide Topical Oil
Subpotent Drug
Class II · Moderate risk
Fluocinolone Acetonide Topical Oil
Subpotent Drug
Class II · Moderate risk
Fluocinolone Acetonide Topical Oil
Subpotent Drug
Class II · Moderate risk
NEOstigmine Methylsulfate
Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.
Class II · Moderate risk
Hydromorphone HCl 1 mg/mL PF INJ. 1mL in a 3mL Sterile…
Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.
Class II · Moderate risk
Morphine Sulfate 4 mg/mL PF Injection. 1 mL in a 3ml Sterile…
Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.
Class II · Moderate risk
Morphine Sulfate 2 mg/mL PF Injection. 1 mL in a 3ml Sterile…
Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.
Class II · Moderate risk
Kit for the Preparation of Technetium TC-99M Mebrofenin
Failed Stability Specifications
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for adhesive transfer.
Class II · Moderate risk
PYRIDOXINE Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr.
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
Class II · Moderate risk
METHYLCOBALAMIN Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr.
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
Class II · Moderate risk
LIPO-PLEX Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr.
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
Class II · Moderate risk
LIPO-DEN PLUS Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr.
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
Class II · Moderate risk
LIPO-DEN EXTREME Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr.
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
Class II · Moderate risk
LIPO-DEN Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr.
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
Class II · Moderate risk
LIPO-B Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr.
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
Class II · Moderate risk
HYDROXOCOBALAMIN Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr.
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
Class II · Moderate risk
ADENO-PLEX Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr.
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
Class II · Moderate risk
CYANOCOBALAMIN Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr.
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
Class II · Moderate risk
Lupron Depot 22.5 mg 3 month Kit NDC 00074-3346-03 84 days supply
Lack of Processing Controls.
Class II · Moderate risk
Kisqali 600 Dose 63 tablet 200 mg NDC 00078-0874-63 28 days supply
Lack of Processing Controls.
Class II · Moderate risk
OPDIVO 40 mg/4 mL SDV NDC 00003-3772-11 28 days supply
Lack of Processing Controls.