FDA Recalls Medroxyprogesterone Acetate Injectable Suspension for Temperature Abuse
McKesson Medical-Surgical recalls 780 vials of medroxyprogesterone acetate injectable suspension nationwide due to temperature exposure during distribution that may affect medication stability.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving temperature abuse of an injectable medication that may affect stability and efficacy. The product constitutes a risk-of-harm item absent reported injury.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling 780 vials of medroxyprogesterone acetate injectable suspension (150 mg/mL, 1 mL single dose vials, NDC 16714-981-01) manufactured by NorthStarRx/Teva Pharma USA. The product was distributed nationwide.
The recall is due to Current Good Manufacturing Practice (cGMP) deviations involving temperature abuse. Temperature exposure during distribution may affect the stability of the medication.
Medroxyprogesterone acetate is a prescription injectable contraceptive. Patients who may have received affected vials should contact their healthcare provider for guidance about whether they received recalled product and what actions, if any, should be taken.
Additional information and product inquiries can be directed to McKesson Medical-Surgical Inc.
The recalled product
- Product
- Medroxyprogesterone acetate injectable suspension, 150 mg/mL, 1 mL single dose vial, Rx only, MFG: NorthStarRx/Teva Pharma USA , NDC 16714-981-01
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Affected units
- 780
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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