Clinical Specialties Compounding Pharmacy Recalls Pap 300 mg-phent 10 mg-prost 100 mcg
Clinical Specialties Compounding Pharmacy is recalling specific lots of Pap 300 mg-phent 10 mg-prost 100 mcg due to FDA inspection findings regarding quality control and lack of assurance of sterility.
What this means for you
Illness, injury, or structural failure has been reported. 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 risk of sterility failure in a compounded pharmaceutical product.
Plain-English summary
Clinical Specialties Compounding Pharmacy is recalling specific lots of Pap 300 mg-phent 10 mg-prost 100 mcg. The recall is being conducted because FDA inspection findings resulted in concerns regarding quality control processes and a lack of assurance of sterility.
The affected product is a 96ml total quantity. The specific lots subject to recall are: Lot number CABDBFAC:52 (Exp date: 5/16/2013), Lot number CABDBBAB:40 (Exp date: 4/11/2013), Lot number CABDCAAC:15 (Exp date: 5/21/2013), Lot number CABDCCAC:75 (Exp date: 5/23/2013), and Lot number CABDAFAD:77 (Exp date: 6/3/2013).
The product was distributed in Florida, Georgia, and South Carolina. Consumers should check their medication for these specific lot numbers and expiration dates. If the product matches the recalled lots, they should stop using it and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- Pap 300 mg-phent 10 mg-prost 100 mcg, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
- Manufacturer
- Clinical Specialties Compounding Pharmacy
- Category
- Drug — Compounded Pharmaceutical
- Affected units
- 96
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)
- Lot number CABDBFAC:52
- Exp date: 5/16/2013
- Lot number CABDBBAB:40
- Exp date: 4/11/2013
- Lot number CABDCAAC:15
- Exp date: 5/21/2013
- Lot number CABDCCAC:75
- Exp date: 5/23/2013 and Lot number CABDAFAD:77
- Exp date: 6/3/2013.
Distribution
Part of a larger recall action
This product is one of 49 recalled by Clinical Specialties Compounding Pharmacy 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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