FDA Drug recall D-1420-2012
Pitocin (Oxytocin Injection, USP) Synthetic 10 units per mL 10 mL, Rx only, Manufactured and Distributed by: JHP Pharmaceuticals, LLC Roche…
- FDA Drug
- Class III
- terminated
- Published 2012-07-25
On 2012-07-25 the FDA classified a Class III recall of Pitocin (Oxytocin Injection, USP) Synthetic 10 units per mL 10 mL, Rx only, Manufactured and Distributed by: JHP Pharmaceuticals, LLC Roche… by Jhp Pharmaceuticals, citing labeling: Label Mix-up: Pitocin storage conditions should be labeled, "Store between 20¿ to 25¿C (68¿ to 77¿F)". Pitocin lot 225867 and part of Pitocin lot 231423 were labeled, "S….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1420-2012 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-06-05 |
| Published | 2012-07-25 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Jhp Pharmaceuticals |
| Distribution | US |
Product
Pitocin (Oxytocin Injection, USP) Synthetic 10 units per mL 10 mL, Rx only, Manufactured and Distributed by: JHP Pharmaceuticals, LLC Rochester, MI 48307 NDC 42023-116-02
Reason
Labeling: Label Mix-up: Pitocin storage conditions should be labeled, "Store between 20¿ to 25¿C (68¿ to 77¿F)". Pitocin lot 225867 and part of Pitocin lot 231423 were labeled, "Store between 20¿ to 25¿C (28¿ to 77¿F)".
Identifiers
| ndc | 42023-116-25 |
|---|---|
| ndc | 42023-116-01 |
| ndc | 42023-116-02 |
| code_info | Lot 231423, 255867 |
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-1420-2012%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.