CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Drugs Recalls
Prescription and over-the-counter medications
Diltiazem CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) 180 mg, 100-count bottles, Rx Only Mfg. By: Actavis 60 Columbia Rd., Bldg. B Morristown, NJ 07960. NDC 63739-284-10
Mckesson Packaging Services
Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Morphine Sulfate 2 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265 Commerical Way Weeki Wachee, FL 34613. NDC 69623-129-10
Premier Pharmacy Labs
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.
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
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
Time-Cap Laboratories
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
LIPO-PLEX Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
Coastal Meds
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
PYRIDOXINE Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
Coastal Meds
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
Subpotent Drug
Diltiazem HCl Extended-Release Capsules, USP 240 mg, 100-count bottles, Rx Only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977. NDC: 63739-016-10
Mckesson Packaging Services
Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
Ibuprofen Tablets, USP, 200 mg, a) 50 tablet (NDC 53943-291-15), b) 100 tablet (NDC 53943-291-12), c) 500 tablet (NDC 53943-291-14), Brown, Distributed by Drug Mart, Food Fair, Medina, Ohio 44256
Time-Cap Laboratories
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Morphine Sulfate 4 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265 Commerical Way Weeki Wachee, FL 34613. NDC 69623-127-10
Premier Pharmacy Labs
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.
Subpotent Drug
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Diltiazem HCl Extended-Release Capsules, USP 120 mg, 100-count bottles, Rx only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977. NDC: 63739-014-10
Mckesson Packaging Services
Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
ADENO-PLEX Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
Coastal Meds
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
LIPO-DEN EXTREME Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
Coastal Meds
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
METHYLCOBALAMIN Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
Coastal Meds
Presence of Particulate matter. Recall due to presence of unknown particulate matter.