Acetaminophen Suspension
FDA Recall NDC 68094-030
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Acetaminophen (NDC 68094-030). A significant event, classified as Class II, was initiated on Nov 01, 2021 by Precision Dose, Inc.. The reported reason for this action was: "cGMP Deviations: Product manufactured with contaminated raw ingredient."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
cGMP Deviations: Product manufactured with contaminated raw ingredient.
Nov 01, 2021
Nov 17, 2021
151,100 unit dose cups
Recall Profile & Regulatory Data
Event ID
88976
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Precision Dose Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA
Termination Date
Jul 14, 2024
Product Description
Acetaminophen Oral Suspension, 325 mg/10.15 mL, packaged in 10.15 mL per cup (NDC Individual cup: 68094-330-59), in a) 30-count case (NDC 30-count case: 68094-330-62), and b) 100-count case (NDC 100-count case: 68094-330-61), Hospital Use Only, Pkg. Precision Dose, Inc., S. Beloit, IL 61080.
Batch or Lot Expiration Information
Lot# : 503679, 503693, 503715
Affected Packages Involved in this Recall
68094-231-59Product
68094-231-62Product
68094-231-61Product
68094-231-01Product
68094-231-58Product
68094-330-59Product
68094-330-62Product
68094-330-61Product
68094-030-59Product
68094-030-62Product
Class II Terminated
cGMP Deviations: Product manufactured with contaminated raw ingredient.
Nov 01, 2021
Nov 17, 2021
166,920 unit dose cups
Recall Profile & Regulatory Data
Event ID
88976
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Precision Dose Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA
Termination Date
Jul 14, 2024
Product Description
Acetaminophen Oral Suspension, 160 mg/5 mL, packaged in 5 mL per cup (NDC Individual cup: 68094-231-59), in a) 30-count case (NDC 30-count case: 68094-231-62), and b) 100-count case (NDC 100-count case: 68094-231-61), Hospital Use Only, Pkg. Precision Dose, Inc., S. Beloit, IL 61080.
Batch or Lot Expiration Information
Lot# : 503670
Affected Packages Involved in this Recall
68094-231-59Product
68094-231-62Product
68094-231-61Product
68094-231-01Product
68094-231-58Product
68094-330-59Product
68094-330-62Product
68094-330-61Product
68094-030-59Product
68094-030-62Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
