Colonia Care Pharmacy Recalls C-Atropine Sulfate Ophthalmic Solution
Colonia Care Pharmacy is recalling C-Atropine Sulfate Ophthalmic Solution 0.01% due to a 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 severity score according to the rubric.
Plain-English summary
Colonia Care Pharmacy is recalling 12 droptainer bottles of C-Atropine Sulfate Ophthalmic Solution 0.01%. The product is a prescription-only medication distributed in New Jersey to specific patients.
The recall was initiated because the sterility of the product cannot be guaranteed. The affected lots are 070119A with a best-use date of 08/15/19, and 072219N with a best-use date of 09/05/19.
Patients who have received this medication should contact their healthcare provider for further instructions.
The recalled product
- Product
- C-ATROPINE SULF OPHTH 0.01%, 5 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
- Manufacturer
- Colonia Care Pharmacy
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 12
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 #: 070119A
- BUD 08/15/19
- 072219N
- BUD 09/05/19
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 32 recalled by Colonia Care 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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