Liberty Drug Recalls 17-Hydroxyprogesterone Injectable Due to Sterility Concerns
Liberty Drug & Surgical is recalling 85 vials of 17-Hydroxyprogesterone injectable because process deficiencies may have compromised 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 and involves a risk of serious injury due to compromised sterility in an injectable product, meeting the criteria for a Severe rating.
Plain-English summary
Liberty Drug & Surgical is recalling 85 vials of 17-Hydroxyprogesterone 250 mg/mL Injectable, 5 mL multi-dose vial. The recall is due to process deficiencies observed in sterile ophthalmic and injectable products that could have compromised the sterility of the product.
The affected product was distributed to physicians, medical facilities, and prescription-specific patients in New Jersey and New York. The recall covers lot numbers 03182015@8 (expiration 07/31/15) and 05112015@7 (expiration 09/24/15).
Patients who have received this medication should contact their healthcare provider for further instructions. The FDA classifies this recall as Class II.
The recalled product
- Product
- 17-Hydroxyprogesterone 250 mg/mL Injectable, 5 mL multi-dose vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
- Manufacturer
- Liberty Drug & Surgical
- Category
- Drug — Injectable
- Hazard
- Affected units
- 85
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 (4)
- Lot #: 03182015@8
- Exp 07/31/15
- 05112015@7
- Exp 09/24/15
Distribution
Part of a larger recall action
This product is one of 25 recalled by Liberty Drug & Surgical 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 25 products in this recall →Related recalls
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