Pitocin Injection Recalled for Incorrect Storage Temperature Labeling
JHP Pharmaceuticals is recalling specific lots of Pitocin (Oxytocin) injection due to a labeling error that displays an incorrect lower storage temperature limit.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a minor labeling error regarding temperature units.
Plain-English summary
JHP Pharmaceuticals, LLC is recalling 26,100 vials of Pitocin (Oxytocin Injection, USP) 10 units per mL, 10 mL. The recall involves Lot 225867 and part of Lot 231423. The product is distributed nationwide and in Puerto Rico.
The recall was initiated due to a labeling error regarding storage conditions. The affected vials are labeled with the instruction "Store between 20 to 25C (28 to 77F)" instead of the correct "Store between 20 to 25C (68 to 77F)". This discrepancy involves the lower limit of the Fahrenheit temperature range.
Healthcare providers and patients should check the labels on their Pitocin vials for the affected lot numbers. If the product is found, it should be returned to the supplier or the manufacturer. The FDA has classified this as a Class III recall, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
The recalled product
- Product
- PITOCIN (OXYTOCIN)
- Brand
- PITOCIN
- Manufacturer
- JHP Pharmaceuticals, LLC
- Category
- Drug — Prescription Injection
- Hazard
- Affected units
- 26,100
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 231423
- 255867
Distribution
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