Medroxyprogesterone acetate injection recalled due to temperature abuse manufacturing deviation
McKesson Medical-Surgical is recalling medroxyprogesterone acetate injectable suspension (150 mg/mL) due to temperature abuse during manufacturing. The affected vials were distributed nationwide; patients should contact their healthcare provider.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries and a theoretical manufacturing hazard. Temperature abuse during production presents a potential risk to drug stability and efficacy, but no confirmed harm occurred, fitting the 'precautionary recall' classification.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling medroxyprogesterone acetate injectable suspension, USP (150 mg/mL), in single-dose vials and 25-vial boxes. The recalled NDCs are 0703-6801-01 (single dose) and 0703-6801-04 (25-count box). A total of 92 cartons (89 cartons of 25 vials and 3 single-vial cartons) were distributed to customers nationwide.
The recall was initiated due to current good manufacturing practice (cGMP) deviations involving temperature abuse during the manufacturing process. Temperature exposure can affect a pharmaceutical product's stability and efficacy. No illnesses or injuries have been reported related to the recalled product.
Patients currently taking this medication should not discontinue treatment without consulting their healthcare provider, as medroxyprogesterone acetate is used for contraception and hormone therapy. Patients and healthcare providers who may have received recalled product should contact their pharmacist or healthcare provider for identification and guidance. McKesson Medical-Surgical has communicated specific lot numbers and shipment dates to customers to identify affected product.
The recalled product
- Product
- Medroxyprogesterone acetate injectable suspension, USP, 150 mg/mL, 1 mL vials, packaged in a) single dose vial (NDC 0703-6801-01), b) 25-count box single dose vials (NDC 0703-6801-04), Rx only, MFG: Teva Pharma USA
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 130 recalled by Mckesson Medical-Surgical Inc. Corporate Office 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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