Amoxicillin Powder, For Suspension
FDA Recall NDC 0093-4161
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 4 recorded enforcement report(s) associated with Amoxicillin (NDC 0093-4161). A significant event, classified as Class II, was initiated on Jan 26, 2022 by Teva Pharmaceuticals Usa, Inc.. The reported reason for this action was: "CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions."
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: Products were exposed to temperatures outside of the products labeled storage conditions.
Jan 26, 2022
Jan 03, 2024
3 units
Recall Profile & Regulatory Data
Event ID
89450
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
CARDINAL HEALTHCARE
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA
Termination Date
Sep 29, 2024
Product Description
AMOXICILLIN for Oral Suspension USP, 400MG/5ML, 100ML (when reconstituted), Manufactured In Canada By: TEVA CANA LIMITED, Toronto, Canada M1B 2K9; Manufactured For: TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454. NDC: 0093-4161-73
Batch or Lot Expiration Information
Batch# Batch 35447184A
Affected Packages Involved in this Recall
0093-2263-01Product
0093-2264-01Product
0093-4160-76Product
0093-4160-78Product
0093-4160-73Product
0093-4155-79Product
0093-4155-73Product
0093-4155-80Product
0093-4161-76Product
0093-4161-78Product
0093-4161-73Product
0093-2267-01Product
0093-2268-01Product
0093-3107-01Product
0093-3107-05Product
0093-3109-53Product
0093-3109-05Product
Class II Terminated
Superpotent drug: Out of specification test result for assay during stability testing.
Jun 24, 2016
Aug 31, 2016
53,328 bottles
Recall Profile & Regulatory Data
Event ID
74540
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva North America
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Feb 07, 2017
Product Description
Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Manufactured In Canada by: Teva Canada Limited, Toronto, Canada, NDC 0093-4161-76
Batch or Lot Expiration Information
Lot# 35434158A, Exp 6/17
Affected Packages Involved in this Recall
0093-2263-01Product
0093-2264-01Product
0093-4160-76Product
0093-4160-78Product
0093-4160-73Product
0093-4155-79Product
0093-4155-73Product
0093-4155-80Product
0093-4161-76Product
0093-4161-78Product
0093-4161-73Product
0093-2267-01Product
0093-2268-01Product
0093-3107-01Product
0093-3107-05Product
0093-3109-53Product
0093-3109-05Product
Class III Terminated
Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. This is an expansion of RES 65050.
Jun 18, 2013
Jul 24, 2013
109,080 Bottles
Recall Profile & Regulatory Data
Event ID
65516
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Dec 24, 2013
Product Description
Amoxicillin for Oral Suspension, USP 200 mg/5 mL, a) 75 mL bottle NDC 0093-4160-78 and b) 100 mL bottle NDC 0093-4160-73, Rx Only, Manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B2K9, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960.
Batch or Lot Expiration Information
Lot# s: a) 35426557A, 35426558A, Exp 08/14; b) 35426554A, 35426555A, 35426556A, Exp 08/14
Affected Packages Involved in this Recall
0093-2263-01Product
0093-2264-01Product
0093-4160-76Product
0093-4160-78Product
0093-4160-73Product
0093-4155-79Product
0093-4155-73Product
0093-4155-80Product
0093-4161-76Product
0093-4161-78Product
0093-4161-73Product
0093-2267-01Product
0093-2268-01Product
0093-3107-01Product
0093-3107-05Product
0093-3109-53Product
0093-3109-05Product
Class III Terminated
Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the inner foil seal of the bottles.
Apr 26, 2013
Jun 19, 2013
758,554 bottles
Recall Profile & Regulatory Data
Event ID
65050
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Dec 24, 2013
Product Description
Amoxicillin for Oral Suspension, USP 400mg/5mL, NDC 0093-4161-78 (75ml) and 0093-4161-73 (100mL)
Batch or Lot Expiration Information
Lot# a) NDC 0093-4161-78 -- lot numbers 35426081A, 35426082A, 35426083A, 35426084A, Exp: 06/2014; 35426648A, Exp 08/2014; 35427222A, 35427224A, 35427226A, 35427223A, 35427227A, 35427228A, Exp 10/2014; and b) NDC 0093-4161-73 -- lot numbers 35426631A, 35426632A, 35426633A, 35426634A, 35426635A, 35426636A, 35426637A, 35426638A, 35426639A, 35426640A, 35426680B, 35426681B, 35426682B, Exp 08/2014; 35426641A, 35426642A, Exp 09/2014.
Affected Packages Involved in this Recall
0093-2263-01Product
0093-2264-01Product
0093-4160-76Product
0093-4160-78Product
0093-4160-73Product
0093-4155-79Product
0093-4155-73Product
0093-4155-80Product
0093-4161-76Product
0093-4161-78Product
0093-4161-73Product
0093-2267-01Product
0093-2268-01Product
0093-3107-01Product
0093-3107-05Product
0093-3109-53Product
0093-3109-05Product
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.
