Reported Apr 24, 2019 · Terminated
Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in (a) 150 mL bottle (NDC 0093-4150-80) (b) 80 mL bottle…
Teva Pharmaceuticals USA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teva Pharmaceuticals USA · 1090 Horsham Rd · North Wales, PA · 19454-1505
Is this the product you have?
- Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in (a) 150 mL bottle (NDC 0093-4150-80) (b) 80 mL bottle (NDC 0093-4150-79), Rx Only
- Manufactured in Canada ByTeva Canada Limited Toronto, Canada, M1B2K9
- Manufactured ForTeva Pharmaceuticals USA, INC. North Wales, PA 19454
- Lot codes and dates
- Lots
(a) Lot # 35436769Aexp. date 05/201935438389A35438390Aexp. date 01/202035440838Aexp. date 10/2020(b) 35437491A35443574Bexp. date 09/2021
- Lots
- Amount recalled
- 171,488 150 mL and 80 mL bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
Subpotent Product: assay results for Amoxicillin were below the specification limits.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Teva Pharmaceuticals USA recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.