Agency classClass IIOur severity:Severe FDA (Drugs)·D-1599-2015·Announced 2015-09-23

Morphine Solution Recalled Due to Sterility Assurance Concerns

The Compounding Pharmacy of America is recalling Morphine 40 mg/ml Solution due to FDA inspection findings of GMP violations that may impact sterility.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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, which corresponds to a 'Severe' rating under the rubric, particularly given the potential for serious injury from non-sterile injectable medication.

Plain-English summary

The Compounding Pharmacy of America is recalling Morphine 40 mg/ml Solution, Sterile-Preservative Free. The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the quality and sterility of the product.

The affected product is a 103 ml total volume solution. All lots distributed between November 2014 and May 2015 are included in this recall. Specific lot codes and expiration dates include 02252015@5 (5/26/2015), 03022015@19 (5/31/2015), 04062015@48 (7/5/2015), and 04212015@23 (7/20/2015). The product was distributed nationwide.

Consumers and healthcare providers should check their inventory for these specific lot numbers and dates. If the product is found, it should be discontinued and returned to the supplier or disposed of according to local regulations. No specific instructions for patient management are provided in the source text, but the lack of assurance of sterility poses a risk of infection if the product is administered.

The recalled product

Product: Morphine 40 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Injectable Solution
Hazard: sterility
gmp-violation

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
02252015@5
5/26/2015
03022015@19
5/31/2015
04062015@48
7/5/2015
04212015@23
7/20/2015

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.

See all 382 products in this recall →

Same manufacturer · The Compounding Pharmacy of America

See all →

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Same hazard · sterility