FDA Drug recall D-0147-2017
Amoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, P.O. Box 18…
- FDA Drug
- Class III
- terminated
- Published 2016-11-30
On 2016-11-30 the FDA classified a Class III recall of Amoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, P.O. Box 18… by West Ward Pharmaceuticals, citing labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0147-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-11-04 |
| Published | 2016-11-30 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | West Ward Pharmaceuticals |
| Distribution | US |
Product
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
Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.
Identifiers
| ndc | 0143-9886-01 |
|---|---|
| ndc | 0143-9886-50 |
| ndc | 0143-9886-75 |
| ndc | 0143-9887-01 |
| ndc | 0143-9887-50 |
| ndc | 0143-9887-75 |
| code_info | Lot #: AS1466A, Exp. Jan 2019 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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FDA Drug · Class III · 2017-11-29 · West Ward Pharmaceuticals - Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials (NDC 0641-6145-01), packaged in 25 x 1 mL Vials per shelf pack (NDC 0641…
FDA Drug · Class III · 2017-11-29 · West Ward Pharmaceuticals - SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, 62.5mg elemental iron/5mL, 10 (5mL vials) per shelf pack, Rx only, Mfd: Hikma Farmace…
FDA Drug · Class III · 2016-12-14 · West Ward Pharmaceuticals - Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-Ward Pharmaceutical Corp
FDA Drug · Class II · 2016-11-30 · West Ward Pharmaceuticals - Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals,…
FDA Drug · Class III · 2016-09-28 · West Ward Pharmaceuticals
All West Ward Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0147-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.