Nephron Sterile Compounding Center PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL) recall — FDA D-1347-2022
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Browse U.S. drug recall enforcement reports from the FDA in a structured, searchable format. Review the recalled product, reason, firm, status, dates, distribution information and FDA classification when available.
10,685 detailed records are currently available in this category.
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit
Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate Upon Arrival", however product is labeled to be stored in a controlled…
Chemical Contamination and Subpotent Drug: FDA analysis found product to contain methanol and below label claim for ethanol.
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
CGMP Deviations: products were stored outside the drug label specifications.
CGMP Deviations: products were stored outside the drug label specifications.
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
CGMP Deviations: products were stored outside the drug label specifications.
CGMP Deviations: products were stored outside the drug label specifications.
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
CGMP Deviations: products were stored outside the drug label specifications.
CGMP Deviations: products were stored outside the drug label specifications.
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets
Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .
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