FDA Drug recall D-807-2013
Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingredient, Rx only, packaged in 6.0 kg drums (labeled as 6,000 kg)…
- FDA Drug
- Class III
- terminated
- Published 2013-07-24
On 2013-07-24 the FDA classified a Class III recall of Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingredient, Rx only, packaged in 6.0 kg drums (labeled as 6,000 kg)… by Bayer Healthcare Pharmaceuticals, citing failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-807-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-06-13 |
| Published | 2013-07-24 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Bayer Healthcare Pharmaceuticals |
| Distribution | CA, NY |
Product
Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingredient, Rx only, packaged in 6.0 kg drums (labeled as 6,000 kg), Bayer Schering Pharma AG, D-13342 Berlin
Reason
Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.
Identifiers
| code_info | Lot 87100040 |
|---|
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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All Bayer Healthcare Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-807-2013%22
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