Morphine Solution Recalled Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Morphine 12.5 mg/ml Solution due to FDA inspection findings of GMP violations that may impact sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility failures in injectable drugs) are categorized as Severe.
Plain-English summary
The Compounding Pharmacy of America is recalling Morphine 12.5 mg/ml Solution, Sterile-Preservative Free. The recall is being conducted because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility.
The affected product is a 151 ml total volume solution. All lots were distributed nationwide between November 2014 and May 2015. Specific lot codes and expiration dates include 03022015@13 (5/31/2015), 03162015@51 (6/14/2015), 04072015@59 (7/6/2015), and 04272015@26 (7/26/2015).
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Morphine 12.5 mg/ml Solution, Sterile-Preservative Free,The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Injectable Solution
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 (9)
- All lots distributed between November 2014 and May 2015
- 03022015@13
- 5/31/2015
- 03162015@51
- 6/14/2015
- 04072015@59
- 7/6/2015
- 04272015@26
- 7/26/2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 382 recalled by The Compounding Pharmacy of America under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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