D-0147-2017 Class III Terminated
FDA drug recall D-0147-2017 was initiated by West-Ward Pharmaceuticals Corp. on Nov 4, 2016 and is designated Class III. Reason for recall: Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed. The recall status is terminated (terminated Jun 16, 2017). Affected quantity: 32,102 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Nov 30, 2016
- Initiation Date
- Nov 4, 2016
- Termination Date
- Jun 16, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32,102 bottles
Product description
Amoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, P.O. Box 183400, Amman 11118 - Jordan, NDC 0143-9887-01
Reason for recall
Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.
Distribution pattern
Nationwide
Code information
Lot #: AS1466A, Exp. Jan 2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0147-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026