Medroxyprogesterone Acetate Injection Recalled for Sterility Assurance
Ideal Specialty Apothecary is recalling Medroxyprogesterone Acetate Injection due to lack of assurance of sterility. The recall affects approximately 57,994 vials distributed nationwide.
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: This is an FDA Class II recall involving a sterile injectable drug product. Lack of sterility assurance in injectable medications poses a risk of serious infection or injury, meeting the Severe classification criteria even though no illnesses have been reported in the source text.
Plain-English summary
Ideal Specialty Apothecary, Inc. dba Ideal Pharmacy is recalling Medroxyprogesterone Acetate Injection, IM, 150 mg/mL, packaged in 1 mL single dose vials. The recall applies to all lots within expiry.
The product is being recalled because the manufacturer cannot assure the sterility of the medication. Medroxyprogesterone Acetate is an injectable contraceptive and hormone therapy drug that must meet strict sterility requirements to be safe for injection.
The affected product was distributed nationwide in the USA. The recall includes approximately 57,994 vials. Patients who have received this product should consult their healthcare provider about whether they need follow-up care or an alternative product.
The recalled product
- Product
- Medroxyprogesterone Acetate Injection, IM, 150 mg/mL, packaged in 1 ml Single Dose Vial, RX Only, Ideal Pharmacy, 2333 Morris Ave, Union, NJ 07083
- Affected units
- 57,994
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 (1)
- All lots within expiry
Distribution
Distributed nationwide across the United States.
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