May 2, 2018DrugsFDA
Coastal Meds, LLC. recalls CYANOCOBALAMIN Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
Hazard: Presence of Particulate matter. Recall due to presence of unknown particulate matter.
May 2, 2018DrugsFDA
Mckesson Packaging Services recalls Diltiazem HCl Extended-Release Capsules, USP 240 mg, 100-count bottles, Rx Only, Mfg. By: Par Pharmaceutical One Ram Rid
Hazard: Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
May 2, 2018DrugsFDA
Mckesson Packaging Services recalls Diltiazem CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) 180 mg, 100-count bottles, Rx Only Mfg. By: Actav
Hazard: Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
May 2, 2018DrugsFDA
Mckesson Packaging Services recalls Diltiazem HCl Extended-Release Capsules, USP 120 mg, 100-count bottles, Rx only, Mfg. By: Par Pharmaceutical One Ram Rid
Hazard: Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
May 2, 2018DrugsFDA
Lyne Laboratories, Inc. recalls Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) 118.28 mL (4 fl.oz.) Rx Only, Manufactured by: Lyne Laboratories,
Hazard: Subpotent Drug
May 2, 2018DrugsFDA
Lyne Laboratories, Inc. recalls Fluocinolone Acetonide Topical Oil, 0.01% (Ear Drops) 20 mL, Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton,
Hazard: Subpotent Drug
May 2, 2018DrugsFDA
Lyne Laboratories, Inc. recalls Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) 118.28 mL (4 fl. oz.) Rx Only, Manufactured by: Lyne Laboratories,
Hazard: Subpotent Drug
May 2, 2018DrugsFDA
Premier Pharmacy Labs Inc recalls NEOstigmine Methylsulfate (1 mg/mL) 3mg per 3mL. 3mL Single Dose Syringe. Premier Pharmacy Labs. 8265 Commercial Way We
Hazard: 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.
May 2, 2018DrugsFDA
Premier Pharmacy Labs Inc recalls Hydromorphone HCl 1 mg/mL PF INJ. 1mL in a 3mL Sterile Single-Dose Syringe. 8265 Commercial Way Weeki Wachee, FL 34613
Hazard: 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.
May 2, 2018DrugsFDA
Premier Pharmacy Labs Inc recalls Morphine Sulfate 4 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265 Commerical Way Weeki Wachee, FL
Hazard: 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.
May 2, 2018DrugsFDA
Premier Pharmacy Labs Inc recalls Morphine Sulfate 2 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265 Commerical Way Weeki Wachee, FL
Hazard: 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.
May 2, 2018DrugsFDA
Bayer HealthCare Pharmaceuticals, Inc. recalls All Alka-Seltzer Plus¿ packages with a full front panel instant Redeemable Coupon (IRC) affixed to the individual carton
Hazard: 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.
May 2, 2018DrugsFDA
Time-Cap Laboratories, Inc. recalls Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 53943-292-15), b) 100 caplets (NDC 53493-292-12), and c) 500 caplets (N
Hazard: CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
May 2, 2018DrugsFDA
Time-Cap Laboratories, Inc. recalls Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 49483-600-05), b) 100 caplets (NDC 49483-600-01), c) 500 caplets (NDC 4
Hazard: CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
May 2, 2018DrugsFDA
Time-Cap Laboratories, Inc. recalls Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 42582-113-10) and b) 500 tablet (NDC 42582-113-18) bottles, Rx, Distrib
Hazard: CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
May 2, 2018DrugsFDA
Time-Cap Laboratories, Inc. recalls Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 49483-604-01) and b) 500 tablet (NDC 49483-604-50) bottles, Rx, Manufac
Hazard: CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
May 2, 2018DrugsFDA
Time-Cap Laboratories, Inc. recalls Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 42582-112-01), b) 500 tablet bottles (NDC 42582-112-18), Rx, Distribute
Hazard: CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
May 2, 2018DrugsFDA
Time-Cap Laboratories, Inc. recalls Ibuprofen Tablets USP 600 mg, a) 100 tablets (NDC 42582-112-10) and b) 500 tablet bottles (NDC 42582-112-18), Rx, Distri
Hazard: CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
May 2, 2018DrugsFDA
Time-Cap Laboratories, Inc. recalls Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 49483-603-01) and b) 500 tablet bottles (NDC 49483-603-50), Rx, Manufac
Hazard: CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
May 2, 2018DrugsFDA
Time-Cap Laboratories, Inc. recalls Ibuprofen Tablets USP 400 mg, 500 tablet bottles (NDC 42582-111-18), Rx, Distributed by Bi-Coastal Pharma International,
Hazard: CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
May 2, 2018DrugsFDA
Time-Cap Laboratories, Inc. recalls Ibuprofen Tablets USP 400 mg, a) 100 tablet (NDC 49483-602-01) and b) 500 tablet (NDC 49483-602-50) bottles, Rx, Manufac
Hazard: CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
May 2, 2018DrugsFDA
Time-Cap Laboratories, Inc. recalls Ibuprofen Tablets, USP, 200 mg, a) 50 tablet (NDC 53943-291-15), b) 100 tablet (NDC 53943-291-12), c) 500 tablet (NDC 53
Hazard: CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
May 2, 2018DrugsFDA
Time-Cap Laboratories, Inc. recalls Ibuprofen Tablets, USP, 200 mg, a) 50 tablets (NDC 49483-601-05), b) 100 tablets (NDC- 49483-601-01), c) 500 tablets (ND
Hazard: CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
April 25, 2018DrugsFDA
Renaissance Lakewood, LLC recalls Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), package in 100 mL bags, Rx
Hazard: Labeling: Label mix-up - A complaint was received of one bag of Fluconazole Injection, Iso-Osmotic Sodium Chloride Diluent, USP, 2mg/mL, 50 mL found within the package of 100 mL bags.
April 25, 2018DrugsFDA
Lupin Pharmaceuticals Inc. recalls Lupin Cefdinir powder for Oral Suspension USP, 250 mg/5 mL in (a) 60 mL packs ( NDC 68180-723-20) and (b) 100 mL packs
Hazard: Superpotent Drug
April 25, 2018DrugsFDA
LEADIANT BIOSCIENCES, INC recalls Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co. Inc. Amity
Hazard: Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.
April 25, 2018DrugsFDA
Partell Specialty Pharmacy recalls Testosterone/Finasteride 80 mg/8 mg pellet, amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101,
Hazard: Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
April 25, 2018DrugsFDA
Partell Specialty Pharmacy recalls Estradiol 55 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, N
Hazard: Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
April 25, 2018DrugsFDA
Partell Specialty Pharmacy recalls Estradiol 50 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, N
Hazard: Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
April 25, 2018DrugsFDA
Partell Specialty Pharmacy recalls Estradiol 40 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, N
Hazard: Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.