FDA Drug recall D-0971-2015
Fluoxetine Capsules USP, 20 mg, packaged in a) 500-count bottles (NDC 50111-648-02), and (b) 1000- count bottles (NDC 50111-648-03), Rx onl…
- FDA Drug
- Class II
- terminated
- Published 2015-05-06
On 2015-05-06 the FDA classified a Class II recall of Fluoxetine Capsules USP, 20 mg, packaged in a) 500-count bottles (NDC 50111-648-02), and (b) 1000- count bottles (NDC 50111-648-03), Rx onl… by Teva Pharmaceuticals Usa, citing chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation f….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0971-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-13 |
| Published | 2015-05-06 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
Product
Fluoxetine Capsules USP, 20 mg, packaged in a) 500-count bottles (NDC 50111-648-02), and (b) 1000- count bottles (NDC 50111-648-03), Rx only, Manufactured by Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960
Reason
Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity.
Identifiers
| ndc | 50111-647-01 |
|---|---|
| ndc | 50111-647-02 |
| ndc | 50111-647-03 |
| ndc | 50111-648-01 |
| ndc | 50111-648-02 |
| ndc | 50111-648-03 |
| ndc | 50111-648-44 |
| code_info | Lot #: a) 6A208123, Exp 8/2015; b) 6A208121, Exp 8/2015. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0971-2015%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.