FDA Recall
Terminated
Historical recordClass II
Baclofen USP (Micronized) for prescription compounding, packaged in a) 25g (NDC 58597-8004-4); b)100g (NDC 58597-8004-6); c) 500g (NDC 58597-8004-7); d) 1000g (NDC 58597-8004-8), RX only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327.
by American Pharmaceutical Ingredients LLC
- Reason
- CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- Published
- February 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Anastrozole USP for prescription compounding, packaged in a) 1g ( NDC 58597-8080-1), b) 5g (NDC 58597-8080-2), c) 25g (NDC 58597-8080-4), RX only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327.
by American Pharmaceutical Ingredients LLC
- Reason
- CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- Published
- February 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Amitriptyline HCl USP for prescription compounding , packaged in a) 25 g (NDC 58597-8003-4); b) 100 g (NDC 58597-8003-6); c) 500 g (NDC 58597-8003-7), d) 1000 g (NDC 58597-8003-8), RX only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327.
by American Pharmaceutical Ingredients LLC
- Reason
- CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- Published
- February 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Calcium Acetate Capsules, 667 mg, 200 Capsules per bottle, Rx Only. Manufactured by Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-026-02
by Nostrum Laboratories Inc
- Reason
- Presence of Foreign Tablets/Capsules
- Published
- February 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Nicardipine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
by PharMEDium Services, LLC
- Reason
- Lack of sterility assurance.
- Published
- February 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dexamethasone Sodium Phosphate added to 5% Dextrose in all strengths, all doses, and all packaging.
by PharMEDium Services, LLC
- Reason
- Lack of sterility assurance.
- Published
- February 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Rocuronium Bromide in all strengths, all doses, and all packaging.
by PharMEDium Services, LLC
- Reason
- Lack of sterility assurance.
- Published
- February 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Methadone HCl Injection in all strengths, all doses, and all packaging.
by PharMEDium Services, LLC
- Reason
- Lack of sterility assurance.
- Published
- February 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Meperidine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
by PharMEDium Services, LLC
- Reason
- Lack of sterility assurance.
- Published
- February 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Esmolol HCl in all strengths, all doses, and all packaging.
by PharMEDium Services, LLC
- Reason
- Lack of sterility assurance.
- Published
- February 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dexamethasone Sodium Phosphate added to 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
by PharMEDium Services, LLC
- Reason
- Lack of sterility assurance.
- Published
- February 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Vecuronium Bromide in Sterile Water for Injection in all strengths, all doses, and all packaging.
by PharMEDium Services, LLC
- Reason
- Lack of sterility assurance.
- Published
- February 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Neostigmine Methylsulfate Injection in all strengths, all doses, and all packaging.
by PharMEDium Services, LLC
- Reason
- Lack of sterility assurance.
- Published
- February 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Labetalol HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
by PharMEDium Services, LLC
- Reason
- Lack of sterility assurance.
- Published
- February 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Nicardipine HCl in all strengths, all doses, and all packaging.
by PharMEDium Services, LLC
- Reason
- Lack of sterility assurance.
- Published
- February 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ropivacaine HCl Injection in all strengths, all doses, and all packaging.
by PharMEDium Services, LLC
- Reason
- Lack of sterility assurance.
- Published
- February 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
HYDROmorphone HCl in 5% Dextrose in all strengths, all doses, and all packaging.
by PharMEDium Services, LLC
- Reason
- Lack of sterility assurance.
- Published
- February 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Atropine Sulfate Injection in all strengths, all doses, and all packaging.
by PharMEDium Services, LLC
- Reason
- Lack of sterility assurance.
- Published
- February 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lidocaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
by PharMEDium Services, LLC
- Reason
- Lack of sterility assurance.
- Published
- February 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Glycopyrrolate in all strengths, all doses, and all packaging.
by PharMEDium Services, LLC
- Reason
- Lack of sterility assurance.
- Published
- February 28, 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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