FDA Recall
Terminated
Historical recordClass II
LIPO-DEN PLUS Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
by Coastal Meds, LLC.
- Reason
- Presence of Particulate matter. Recall due to presence of unknown particulate matter.
- Published
- May 2, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
LIPO-DEN EXTREME Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
by Coastal Meds, LLC.
- Reason
- Presence of Particulate matter. Recall due to presence of unknown particulate matter.
- Published
- May 2, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
LIPO-DEN Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
by Coastal Meds, LLC.
- Reason
- Presence of Particulate matter. Recall due to presence of unknown particulate matter.
- Published
- May 2, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
LIPO-B Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
by Coastal Meds, LLC.
- Reason
- Presence of Particulate matter. Recall due to presence of unknown particulate matter.
- Published
- May 2, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
HYDROXOCOBALAMIN Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
by Coastal Meds, LLC.
- Reason
- Presence of Particulate matter. Recall due to presence of unknown particulate matter.
- Published
- May 2, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ADENO-PLEX Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
by Coastal Meds, LLC.
- Reason
- Presence of Particulate matter. Recall due to presence of unknown particulate matter.
- Published
- May 2, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
CYANOCOBALAMIN Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
by Coastal Meds, LLC.
- Reason
- Presence of Particulate matter. Recall due to presence of unknown particulate matter.
- Published
- May 2, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
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
by Mckesson Packaging Services
- Reason
- Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
- Published
- May 2, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
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
by Mckesson Packaging Services
- Reason
- Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
- Published
- May 2, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
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
by Mckesson Packaging Services
- Reason
- Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
- Published
- May 2, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
NEOstigmine Methylsulfate (1 mg/mL) 3mg per 3mL. 3mL Single Dose Syringe. Premier Pharmacy Labs. 8265 Commercial Way Weeki Wachee, FL 34613 NDC 69623-234-14.
by Premier Pharmacy Labs Inc
- Reason
- 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.
- Published
- May 2, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Hydromorphone HCl 1 mg/mL PF INJ. 1mL in a 3mL Sterile Single-Dose Syringe. 8265 Commercial Way Weeki Wachee, FL 34613 NDC 69623-249-10
by Premier Pharmacy Labs Inc
- Reason
- 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.
- Published
- May 2, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by Premier Pharmacy Labs Inc
- Reason
- 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.
- Published
- May 2, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by Premier Pharmacy Labs Inc
- Reason
- 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.
- Published
- May 2, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
All Alka-Seltzer Plus¿ packages with a full front panel instant Redeemable Coupon (IRC) affixed to the individual carton. The recalled products can be identified by checking the Bayer logo located on the lower left corner of the front of the carton. If the logo has an orange or green background, the product is included in the recall.
by Bayer HealthCare Pharmaceuticals, Inc.
- Reason
- Labeling: Label Mix-Up: Bayer is recalling all Alka-Seltzer Plus packages, with a green or orange Bayer logo located on the lower left corner of the front of the carton, because the ingredients on the front sticker may not match the actual product in the carton.
- Published
- May 2, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 53943-292-15), b) 100 caplets (NDC 53493-292-12), and c) 500 caplets (NDC 53493-292-14) bottles, Distributed by Drug Mart, Food Fair, Medina, Ohio 44256, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India
by Time-Cap Laboratories, Inc.
- Reason
- CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
- Published
- May 2, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 49483-600-05), b) 100 caplets (NDC 49483-600-01), c) 500 caplets (NDC 49483-600-50), and d) BULK (NDC 49483-600-00) bottles, Rx, Manufactured for: Time Cap labs, Inc., Farmingdale, NY 11735, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India
by Time-Cap Laboratories, Inc.
- Reason
- CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
- Published
- May 2, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by Time-Cap Laboratories, Inc.
- Reason
- CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
- Published
- May 2, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 49483-604-01) and b) 500 tablet (NDC 49483-604-50) bottles, Rx, Manufactured for: Time Cap labs, Inc., Farmingdale, NY 11735, USA, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India
by Time-Cap Laboratories, Inc.
- Reason
- CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
- Published
- May 2, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by Time-Cap Laboratories, Inc.
- Reason
- CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
- Published
- May 2, 2018
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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