Class II · Moderate risk
OZURDEX (dexamethasone intravitreal implant)
GMP Deviations: A silicone particulate was noted in Ozurdex.
FDA Drug Recalls
30 recalls · Class II, newest first
Class II · Moderate risk
Estradiol Tablets
Presence of foreign tablet/capsule: A single foreign tablet was found in pharmacy dispensed bottle of 30 Estradiol 2 mg tablets.
Class II · Moderate risk
Quetiapine Tablets USP 400 mg
Presence of Foreign Substance; metal shard found in tablet
Class II · Moderate risk
Antacid Tablets
Presence of foreign substance: Product found to contain metal particles.
Class II · Moderate risk
GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle
Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.
Class II · Moderate risk
Gentamicin Sulfate Ophthalmic Solution
Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing.
Class II · Moderate risk
Tizanidine HCl Tablets
Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets .
Class II · Moderate risk
Cefuroxime 10mg/mL INJ 0.5 mg
Presence of Particulate Matter: Particulate matter was reported in one lot of Cefuroxime by a physician after use of product.. FDA analysis identified the particulate as coring of the rubber stopper
Class II · Moderate risk
Lisinopril Tablets USP
Presence of Foreign Substance: Product complaint was received of metal contaminant observed in one tablet.
Class II · Moderate risk
Dymista (azelastine hydrochloride and fluticasone propionate)
Presence of foreign substance: Potential for glass in the neck area of the glass bottles.
Class II · Moderate risk
Testosterone Cypionate Injection
Presence of Particulate Matter: organic and inorganic compounds detected in vials of product.
Class II · Moderate risk
Metformin Hydrochloride Extended Release Tablets
Presence of foreign substance: One lot fo Metformin Hydrochloride Extended Release Tablets, USP, 500 mg (500 Count) contains foreign matter identified as a piece of rubber glove detected in one tablet.
Class II · Moderate risk
Fluticasone propionate Nasal Spray
Presence of foreign substance: glass particles
Class II · Moderate risk
Atorvastatin Calcium Tablets
Presence of Foreign Substance: A product complaint was received for a defective tablet with an embedded foreign object observed in a bottle.
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.
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
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.